Mask system headgear

ABSTRACT

A respiratory mask system includes a headgear that, in use, secures the respiratory mask system to a patient&#39;s head. The headgear includes a pair of forehead straps that are coupled together by a forehead coupler to form a closed loop. The forehead coupler is removably connected to a frame of the respiratory mask such that the forehead straps remain in a closed loop. The pair of forehead straps can also be coupled together by positioning a male strap portion within an aperture of a female strap portion. The male strap portion has a free end that is configured to be received into the aperture. The male strap portion includes a plurality of notches that engage the aperture of the female strap portion and provide incremental adjustment. The free ends of the male and female strap portions have fasteners configured to engage the surface of the other strap portion.

INCORPORATION BY REFERENCE TO PRIORITY APPLICATIONS

This application is related to and claims priority from U.S. ProvisionalPatent Application No. 62/128,434, U.S. Provisional Patent ApplicationNo. 62/187,010 and U.S. Provisional Patent Application No. 62/268,341,the entireties of which are hereby incorporated by reference herein andmade a part of the present disclosure.

BACKGROUND Technical Field

The present disclosure generally relates to masks for use in providingrespiratory therapies such as, but not limited to, constant positiveairway pressure (CPAP) and non-invasive ventilation (NIV). Moreparticularly, the present disclosure relates to a headgear connectionassembly configured to provide an improved reliability and ease of usefor full face, nasal, nasal pillows, cannulas, and other masks orinterfaces.

Description of the Related Art

Respiratory masks are used to provide therapies for the treatment of avariety of respiratory conditions including but not limited to CPAP andNIV. The present disclosure will be described in relation to CPAPtherapy, however it is to be understood that it may be equallyapplicable to other therapies.

CPAP therapy is used in the treatment of obstructive sleep apnea (OSA),a condition in which the back of the throat relaxes so much whilesleeping that it narrows or entirely blocks the airway. With theconstriction or closure of the airway, breathing can stop or become veryshallow for a few seconds or longer. CPAP splints open the airway byproviding a constant flow of pressurized air to the airway via aninterface such as a mask. For the therapy to be effective, asubstantially leak free seal ideally should be maintained between themask and a user's face. In order to achieve this, a headgear system canbe used to secure the mask to a user's face. It is commonly known in theart for there to be a headgear connection assembly between a headgearand a mask. The headgear is adapted to engage with a mask such that asealing cushion is held in position against the patient's face. Theheadgear often includes a number of headgear straps including anadjustable crown strap for adjusting the size of the headgear to match arange of patient head sizes. The crown strap can include two strapportions that are joined together by a buckle at a centrally locatedpoint on the top of a patients head.

Some problems exist with prior headgear connection assemblies. Forexample, the buckle can be bulky and/or hard on a patient's head. Also,the adjustment can be difficult and ambiguous because there are nomarkers to indicate how much adjustment has been made to the length ofthe crown strap. These problems may lead to the mask and headgear systemlacking ease of use, reliability and/or comfort, which in turn mayresult in poor user compliance. Trial and error may be required to refitthe headgear and mask every time it is disconnected and reconnected forcleaning. This can be time consuming and inconvenient for patients.Previous designs can also result in uneven adjustment of each of thestrap portions that may cause the headgear to sit lopsided on apatient's head, which may result in leaks and compromise the efficacy ofthe therapy.

There is a continuous need in the art for headgear that is comfortable,fits a wide range of patient's, and is easily adjusted and assembled. Itis known in the art for the headgear straps of such headgears to beindividually assembled to the frame of the respiratory mask. Headgearsassembled in this way can be fiddly and time consuming to fit, size,adjust and assemble, which may influence a patient's compliance withtheir therapy.

It is an objective of the invention to at least partially address one ormore of these problems. Alternatively, it is an object of the inventionsto at least provide a useful choice to the public.

BRIEF SUMMARY

An object of the present disclosure is to provide a respiratory masksystem which will at least provide the public with a useful choice.

In accordance with certain features, aspects and advantages of at leastone of the configurations disclosed herein, a respiratory mask system isprovided. The respiratory mask system comprises a frame, a sealingcushion provided to the frame, for sealingly engaging with a patient'sface, a headgear to retain the respiratory mask on a patient's head, anda forehead coupler. The forehead coupler comprises a pair of strapconnectors, a frame connector, and a flexible linking member, whereinthe strap connectors are spaced apart and connected by the flexiblelinking member, which extends there between.

In some configurations, the headgear comprises at least two foreheadstraps for connecting to the strap connectors of the forehead coupler.

In some configurations, the forehead straps and forehead coupler connecttogether to form an adjustable closed loop about a patient's head.

In some configurations, the frame comprises a forehead support and theforehead support comprises a coupler connection.

In some configurations, the coupler connection comprises an aperture forreceiving the frame connector.

In some configurations, the frame connector is removably coupled to thecoupler connection.

In some configurations, the forehead coupler is removably attached tothe frame such that the closed loop remains intact.

In some configurations, the flexible linking member provides independentmovement of each strap connector.

In some configurations, the flexible linking member conforms to theshape of the patient's forehead in use.

In some configurations, the frame connector comprises a tongue and thecoupler connection comprises a fork, such that a tongue and fork jointis formed between the frame and forehead coupler.

In some configurations, the forehead coupler comprises a T-shapedprofile. The T-shaped profile comprises a stem, being formed by theframe connector, and a pair of laterally extending arms, being formed bythe strap connectors.

In accordance with certain features, aspects and advantages of anotherone of the configurations disclosed herein, a respiratory mask system isprovided. The respiratory mask system comprises a frame, a sealingcushion, a headgear and a forehead coupler. The frame comprises aforehead support. The sealing cushion is provided to the frame, and isconfigured to sealingly engage with a patient's face. The headgear hasat least two forehead straps and is configured to retain the respiratorymask system on a patient's head. The forehead coupler connects theforehead straps in a closed loop such that the in-use length of thestraps is adjustable, and couples the headgear to the forehead supportsuch that the strap connectors can flex in more than one directionrelative to the frame.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, a connector systemfor connecting a headgear to a respiratory mask is provided. Theconnector system comprises a frame connected to the respiratory mask,and first and second forehead straps attached to the headgear. The firstand second forehead straps are attached to the frame to connect theheadgear to the respiratory mask.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, a connector systemfor fastening first and second forehead straps of a headgear to a frameof a respiratory mask is provided. The connector system comprises a slotdisposed on the frame, and a forehead strap connector having a strapconnecting portion and a frame connector portion. The strap connectingportion is connected to the first and the second forehead straps, andthe frame connector portion extends from the strap connecting portion.The frame connector portion is positioned within the slot and the frameis retained between the frame connector portion and the strap connectingportion such that the headgear is attached to the frame. In someconfigurations, the strap connecting portion is attached to at least onestrap connector through which the first and second forehead straps areattached to the forehead strap connector.

In some configurations, the strap connecting portion includes slots thatextend through the strap connecting portion, through which the first andsecond forehead straps are attached to the forehead strap connector.

In some configurations, the strap connecting portion and the frameconnector portion of the forehead strap connector are integrally formedfrom a fabric strip, wherein the frame connector portion is formed byoverlapping and fusing or otherwise connecting a portion of the fabricstrip onto itself.

In some configurations, an inlet portion of the slot has a width that isnarrower than a thickness of the strap connecting portion.

In accordance with certain features, aspects and advantages of still yetanother one of the configurations disclosed herein, a connector systemfor fastening first and second forehead straps of a headgear to a frameof a respiratory mask is provided. The connector system comprises aconnection portion disposed on the frame, and a forehead strapconnector. The forehead strap connector further comprises slotsextending through the forehead strap connector, the first and secondforehead straps being attached to the forehead strap connector via theslots, and a fabric loop, the fabric loop being attached to the foreheadstrap connector between the slots and extending outward from theforehead strap connector. The fabric loop is fastened onto theconnection portion such that the headgear is attached to the frame.

In some configurations, the forehead strap connector has a center columnthat defines portions of each slot, wherein the fabric loop is a closedloop and the center column is positioned within the fabric loop.

In some configurations, the fabric loop is fastened to one side of theforehead strap connector, extends through the forehead strap connector,and extends outward from an opposite side of the forehead strapconnector.

In some configurations, the forehead strap connector is configured to beseparable into a first portion and a second portion, the first portionincluding a first slot and having an end of the fabric loop attached tothe first portion, the second portion including a second slot and havingan end of the fabric loop attached to the second portion, wherein thefirst portion is configured to be removably fastened to the secondportion, and wherein the fabric loop is a closed loop when the firstportion is fastened to the second portion, and an open loop when thefirst portion is unfastened from the second portion.

In some configurations, a protrusion extends outward from the firstportion and a hole is recessed into the second portion, wherein theprotrusion is positioned into the hole to fasten the first portion andthe second portion.

In some configurations, the connection portion is an elongate post.

In some configurations, the connection portion is a gap, and the fabricloop is positioned within the gap to fasten the headgear to the frame.

In accordance with certain features, aspects and advantages of anotherone of the configurations disclosed herein, a connector system forfastening first and second forehead straps of a headgear to a frame of arespiratory mask is provided. The connector system comprises aconnection portion disposed on the frame, and a forehead strapconnector. The forehead strap connector further comprises a first fabriclayer joined with a second fabric layer, the first and second fabriclayers being bonded to each other at their ends, a connection cavitypositioned between the first and second fabric layers, and slotspositioned on and extending through the ends of the first and secondfabric layers. The first and second forehead straps are attached to theforehead strap connector via the slots and the forehead strap connectoris positioned onto the connection portion such that the headgear isattached to the frame.

In some configurations, the forehead strap connector further comprisesover-moulded slot liners formed around a perimeter of the slot strapsand extending through the first and second fabric layers, wherein theover-moulded slot liners bond the first and second fabric layers attheir ends.

In some configurations, the flexibility of the first and second fabriclayers vary between planes.

In some configurations, the first and second fabric layers are moreflexible in a direction that is substantially perpendicular to thethickness of the fabric than in a direction that is parallel to thethickness.

In some configurations, the connection portion is a gap, and the fabricloop is positioned within the gap to fasten the headgear to the frame.

In accordance with certain features, aspects and advantages of anotherone of the configurations disclosed herein, a connector system forfastening first and second forehead straps of a headgear to a frame of arespiratory mask is provided. The connector system comprises aconnection portion disposed on the frame, and a forehead strapconnector. The forehead strap connector further comprises a first fabriclayer joined with a second fabric layer, the first and second fabriclayers being bonded to each other at their ends, a connection cavitypositioned between the first and second fabric layers, and slotspositioned on and extending through the ends of the first and secondfabric layers. The first and second forehead straps are attached to theforehead strap connector via the slots and the forehead strap connectoris positioned onto the connection portion such that the headgear isattached to the frame.

In some configurations, the forehead strap connector further comprisesover-moulded slot liners formed around a perimeter of the slot strapsand extending through the first and second fabric layers, wherein theover-moulded slot liners bond the first and second fabric layers attheir ends.

In some configurations, the flexibility of the first and second fabriclayers vary between planes.

In some configurations, the first and second fabric layers are moreflexible in a direction that is substantially perpendicular to thethickness of the fabric than in a direction that is parallel to thethickness.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, a connector systemfor fastening a forehead band of a headgear to a frame of a respiratorymask is provided. The connector system comprises slots disposed on theframe, and a fastener disposed on the forehead band. The forehead bandextends through the slots and the forehead band is overlapped andfastened onto itself to fasten the headgear to the frame.

In some configurations, the fastener is a hook and loop fastener.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, connector system forremovably connecting first and second forehead straps of a headgear to aframe is provided. The connector system comprises a hook connectorportion disposed on the frame and a strap connector portion connected tothe first and second forehead straps. The hook connector portion furtherincludes a shank connected to the frame, a bend connected to the shank,a return arm connected to the bend, and a throat portion positionedbetween the shank and the return arm. The strap connector portion has anattachment portion configured to be removably inserted into the throatportion. The attachment portion is sandwiched between the shank and thereturn arm such that the strap connector portion is removably attachedto the hook connection portion.

In some configurations, the hook connector portion includes a ribextending into the throat portion from the shank toward the return arm.The strap connector portion includes a rib slot positioned on theattachment portion. The rib is positioned within the rib slot when thestrap connector portion is attached to the hook connection portion andcontact between the rib and the rib slot obstructs rotation of the strapconnector relative to the frame.

In some configurations, the rib contacts the bend and the return arm.

In some configurations, the rib is separated from the bend and thereturn arm.

In some configurations, the attachment portion includes a blockingportion positioned on one side of the attachment portion. The blockingportion contacts the return arm and obstructs the strap connectorportion from being inserted into the throat portion when the blockingportion faces the return arm.

In some configurations, an end portion of the return arm extends towardsthe shank to define a throat opening between the return arm and theshank. A width of the throat opening between the return arm and theshank is narrower than a width of the throat between the return arm andthe shank.

In some configurations, a thickness of a first end of the attachmentportion is less than the width of the throat opening, and a thickness ofa second end of the attachment portion is greater than double the widthof the throat opening.

In some configurations, the strap connector includes slots through whichthe straps are connected.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, a connector systemfor connecting first and second forehead straps of a headgear to a frameis provided. The connector system includes a female coupling portiondisposed on the universal frame and having a receiving portion, and amale coupling portion. The male coupling portion includes slots throughwhich the first and second forehead straps are attached, and anattachment portion positioned between the slots. The attachment portionof the male coupling portion is positioned within the receiving portionof the female coupling portion to connect the first and second foreheadstraps to the frame.

In some configurations, the frame is a universal frame configured to fita plurality of respiratory mask sizes.

In some configurations, a position of the attachment portion withrespect to the slots varies between a smaller-sized respiratory mask anda larger-sized respiratory mask.

In some configurations, comparatively, the position of the attachmentportion with respect to the slots for the smaller-sized respiratory maskis positioned vertically higher than the attachment portion with respectto the slots for the larger-sized respiratory mask such that the slotsfor the smaller-sized respiratory mask are positioned lower with respectto the universal frame than the slots for the larger-sized respiratorymask.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, a method of using auniversal frame for different respiratory mask sizes is provided. Theuniversal frame is removably attachable to a connector element. Theconnector element is attached to first and second forehead straps of aheadgear and has an attachment portion that attaches to the universalframe. The method includes providing different connector elements forthe different respiratory mask sizes, and varying the position of theattachment portion on the different connector elements according torespiratory mask size.

In some configurations, varying the position of the attachment portionon the different connector elements according to respiratory mask sizeincludes positioning the attachment portion of a smaller-sizedrespiratory mask vertically higher with respect to the universal framethan the attachment portion of a larger-sized respiratory mask such thatthe first and second forehead straps for the smaller-sized respiratorymask are positioned lower with respect to the universal frame than thefirst and second forehead straps for the larger-sized respiratory mask.

In some configurations, the connector element has slots through whichthe first and second forehead straps are attached.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, connector system forremovably fastening a headgear to a frame of a respiratory mask thatallows forehead straps of the headgear to be connected and disconnectedfrom the frame without unfastening the top straps is provided. Theconnector system comprises a fastener portion disposed on the frame, anda forehead strap connector connected to the forehead straps. Theforehead strap connector further comprises a fastener engaging portiondisposed on the forehead strap connector and configured to selectivelyengage the fastener portion to connect and disconnect the top straps tothe frame.

In some configurations, the fastener portion includes an elongate postand the fastener engaging portion comprises a flexible loop, wherein theflexible loop is removably fitted over the post to connect anddisconnect the top straps to the frame.

In some configurations, the fastener portion includes a hook portion andthe fastener engaging portion comprises a crossbar, wherein the crossbaris removably fitted within the hook portion to connect and disconnectthe top straps to the frame.

In some configurations, the fastener portion includes a slot and thefastener engaging portion comprises a neck portion extending from theforehead strap connector and a head portion positioned on a free end ofthe neck portion, wherein the neck portion is removably positionedwithin the slot to connect and disconnect the top straps to the frame.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, a method forremovably fastening a headgear to a frame of a respiratory mask thatallows forehead straps of the headgear to be connected and disconnectedfrom the frame without unfastening the forehead straps is provided. Themethod comprises providing a forehead strap connector that is removablyfastenable to the frame, attaching the forehead straps to the foreheadstrap connector, fastening the forehead strap connector to the frame toconnect the forehead straps to the frame, and unfastening the foreheadstrap connector from the frame to disconnect the forehead straps fromthe frame.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, a top strapconnection assembly for providing incremental length adjustment to a topstrap of a headgear is provided. The top strap connection assemblyincludes a female strap portion attached to the headgear and a malestrap portion attached to the headgear. The female strap portionincludes an aperture extending through the female strap portion, and afirst fastener portion positioned on an inner surface of the femalestrap between the aperture and an end of the female strap portion. Themale strap portion includes a plurality of notches positioned along thelength of the male strap portion on outer edges of the male strapportion, and a second fastener portion positioned on an inner surface ofthe male strap portion between the plurality of notches and an end ofthe male strap portion. The male strap is positioned within the aperturesuch that the plurality of notches engages the aperture. The firstfastener portion is fastened to an outer surface of the male strapportion and the second fastener portion is fastened to an outer surfaceof the female strap portion.

In some configurations, the first and second fasteners portions are hookportions of a hook and loop type fastener.

In some configurations, the first and second fastener portions include athree-dimensional projection that protrudes from the inner surfaces ofthe female and male strap portions.

In some configurations, the aperture extends through a portion of thefirst fastener portion.

In some configurations, a width of the female strap portion isapproximately equal to a width of the male strap portion.

In some configurations, the aperture has a straight side and a curvedside.

In some configurations, a length of a perimeter of the curved side issubstantially equal to the width of the male strap portion.

In some configurations, the plurality of notches on the outer edges ofthe male strap portion are arranged in aligned pairs and the male strapportion includes a width between each aligned pair of notches, andwherein the width between each aligned pair of notches is substantiallyequal to a length of the straight side of the aperture.

In some configurations, the aperture has a height extending along thelength of the male strap portion and the height of the aperture is lessthan the length of the straight side of the aperture.

In some configurations, the width of the male strap portion isapproximately between 1.5 and 2.5 times greater than a length of thestraight side of the aperture.

In some configurations, the aperture has a semicircular shape andincludes a straight side extending perpendicular to a longitudinal axisof the female strap portion.

In accordance with certain features, aspects and advantages of yetanother one of the configurations disclosed herein, there is provided aheadgear assembly for a respiratory mask, the headgear including a malestrap portion and a female strap portion. The free end portion of thefemale strap portion includes an aperture through which the free endportion of the male strap portion passes and the male strap portionengages the aperture to allow incremental adjustment of the overallstrap length. In some embodiments, the male strap portion comprises aplurality of notches that engage the aperture of the female strapportion.

In some embodiments, the headgear assembly comprises a top strap havinga male strap portion and a female strap portion. The female strapportion comprises a first free end having an aperture extendingtherethrough. In some embodiments the aperture extends through a lengthof the first free end of the strap, including extending through theinner surface and the outer surface. The female strap portion alsocomprises a first fastener portion supported by the inner surface of thefemale strap at the free end. The male strap portion comprises a secondfree end and a plurality of notches adjacent the second free end. Thenotches are configured to engage the aperture and limit movement of themale strap portion within the aperture when the male strap portion isflattened. The male strap portion can also comprise a second fastenersupported by the inner surface of the male strap portion at its freeend.

In some preferred embodiments, the headgear assembly comprises first andsecond fasteners that are hook portions of a hook and loop typefastener. In some preferred embodiments, each of the first and secondfree ends includes a three dimensional projection.

In some preferred embodiments, the headgear assembly includes a femalestrap portion having an aperture with one straight side and one curvedside. In some preferred embodiments, the aperture extends through aportion of the first fastener portion.

Further aspects of the presently disclosed subject matter, which shouldbe considered in all its novel aspects, will become apparent to thoseskilled in the art upon reading of the following description whichprovides at least one example of a practical application of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a system for providing heated humidifiedgases to a user, such as a continuous positive airway pressure system asmight be used in conjunction with the respiratory mask of the presentdisclosure.

FIG. 2 is a front perspective view of a respiratory mask system that isarranged and configured in accordance with certain features, aspects andadvantages of the present disclosure.

FIG. 3 is a front view of the frame of FIG. 2.

FIG. 4 is a perspective view of the headgear and forehead coupler, ofFIG. 2, assembled together.

FIG. 5A is a front view of the forehead coupler of FIG. 2.

FIG. 5B is a top view of the forehead coupler of FIG. 2.

FIG. 6 is a top perspective view of the frame and forehead coupler, ofFIG. 2, assembled together.

FIG. 7 is a top view of a forehead coupler.

FIG. 8 is a top view of a forehead coupler.

FIG. 9A is a front view of a forehead coupler assembled to a foreheadstrap.

FIG. 9B is a top view of the forehead coupler of FIG. 9A.

FIG. 9C is a rear perspective view of the strap connector of FIGS. 9Aand 9B.

FIG. 10A is a rear perspective view of another embodiment of theforehead coupler of FIGS. 9A and 9B.

FIG. 10B is a top view of the forehead coupler of FIG. 10A.

FIG. 10C is a front perspective view of the forehead coupler of FIG.10A.

FIG. 11A is a top perspective of another embodiment of the foreheadcoupler of FIGS. 9A and 9B.

FIG. 11B is a rear view of the forehead coupler of FIG. 11A.

FIG. 11C is a rear view of the forehead coupler of FIGS. 11A and 11B ina disconnected configuration.

FIG. 12A is a top perspective view of a forehead coupler.

FIG. 12B is a top view of the forehead coupler of FIG. 12A.

FIG. 13A is a side view of a coupler connection assembled to theforehead coupler of FIGS. 9A, 9B and 9C.

FIG. 13B is a side view of the coupler connection of FIG. 13A.

FIG. 14A is a perspective view of a coupler connection disconnected froma forehead coupler.

FIG. 14B is a perspective view of the coupler connection of FIG. 14Aassembled to a forehead coupler.

FIG. 15A is a front view of a coupler connection disconnected from theforehead coupler of FIGS. 9A, 9B and 9C.

FIG. 15B is a perspective view of the coupler connection of FIG. 15Aconnected to the forehead coupler of FIGS. 9A, 9B and 9C.

FIG. 16A is a perspective view of a headgear to frame connection in anon-secured configuration.

FIG. 16B is a perspective view of the headgear to frame connection ofFIG. 16A in a secured configuration.

FIG. 17A is a perspective view of a forehead coupler assembled to acoupler connection.

FIG. 17B is a front view of the forehead coupler and coupler connectionof FIG. 17A.

FIG. 17C is a top view of the forehead coupler and coupler connection ofFIGS. 17A and 17B.

FIG. 17D is a cross-sectional side view of the forehead coupler andcoupler connection of FIGS. 17A to 17C.

FIG. 17E is a perspective view of the coupler connection of FIGS. 17A to17D.

FIG. 18A is an exploded perspective view of a forehead coupler andcoupler connection.

FIG. 18B is a front view of the forehead coupler of FIG. 18A.

FIG. 18C is a cross-sectional side view of the forehead coupler andcoupler connection of FIGS. 18A and 18B, assembled together.

FIG. 18D is cross-sectional side view of the forehead coupler andcoupler connection of FIGS. 18A to 18C, wherein the forehead coupler isin the only orientation that allows for a complete and correct assemblybetween the forehead coupler and the coupler connection.

FIG. 18E is cross-sectional side view of the forehead coupler andcoupler connection of FIGS. 18A to 18C, wherein the forehead coupler isin an orientation that does not allow assembly between the foreheadcoupler and the coupler connection.

FIG. 18F is cross-sectional side view of the forehead coupler andcoupler connection of FIGS. 18A to 18C, wherein the forehead coupler isin an orientation that does not allow assembly between the foreheadcoupler and the coupler connection.

FIG. 18G is cross-sectional side view of the forehead coupler andcoupler connection of FIGS. 18A to 18C, wherein the forehead coupler isin an orientation that does not allow assembly between the foreheadcoupler and the coupler connection.

FIG. 19A is a perspective view of a forehead coupler assembled to thecoupler connection of FIGS. 13A and 13B.

FIG. 19B is a front view of the forehead coupler and coupler connectionof FIG. 19A.

FIG. 19C is a top view of the forehead coupler and coupler connection ofFIGS. 19A and 19B.

FIG. 19D is a cross-sectional side view of the forehead coupler andcoupler connection of FIGS. 19A to 19C.

FIG. 20A is a perspective view of a forehead coupler assembled to acoupler connection.

FIG. 20B is a perspective view of the forehead coupler of FIG. 20A.

FIG. 20C is a front view of the forehead coupler of FIG. 20A.

FIG. 20D is a rear view of the forehead coupler of FIG. 20A.

FIG. 20E is a cross-sectional view of the forehead coupler of FIG. 20A.

FIG. 20F is a top-down view of the forehead coupler of FIG. 20A.

FIG. 20G is a side view of a frame that connects with the foreheadcoupler of FIG. 20A.

FIG. 20H is a rear view of the frame that connects with the foreheadcoupler of FIG. 20A.

FIG. 20I is a cross-sectional side view of the frame and the foreheadcoupler of FIGS. 20A to 20H.

FIG. 20J is a cross-sectional side view of the forehead coupler insertedinto the frame of FIGS. 20A to 20H.

FIG. 20K is a cross-sectional side view of the frame and the foreheadcoupler of FIGS. 20A to 20H.

FIG. 21A is a front view of a universal frame connected to a size smallforehead coupler.

FIG. 21B is a front view of the universal frame connected to a sizemedium/large forehead coupler.

FIG. 21C is a front perspective view of the size small forehead coupleroverlaid over the size medium/large forehead coupler when connected tothe universal frame.

FIG. 22A is a front view of the size medium forehead coupler of FIG.21B.

FIG. 22B is a front view of the size small forehead coupler of FIG. 21A.

FIG. 23A is a rear view of the size medium forehead coupler of FIG. 21B.

FIG. 23B is a rear view of the size small forehead coupler of FIG. 21A.

FIG. 24A is a side view of the size medium forehead coupler of FIG. 21B.

FIG. 24B is a side view of the size small forehead coupler of FIG. 21A.

FIG. 25A is a side cross-sectional view of the size medium foreheadcoupler of FIG. 21B.

FIG. 25B is a side cross-sectional view of the size small foreheadcoupler of FIG. 21A.

FIG. 26 shows a perspective view of a prior respiratory mask.

FIG. 27 shows a bottom view of an embodiment of the headgear strap ofthe present disclosure.

FIG. 28 shows a top view of the headgear strap of FIG. 27.

FIG. 29 shows a closer top view of the headgear strap of FIG. 27.

FIG. 30 shows top view of the headgear strap of FIG. 27 as the maleportion is inserted into the aperture of the female portion.

FIG. 31 shows perspective view of the headgear strap of FIG. 27 as themale portion is inserted into the aperture of the female portion.

FIG. 32 shows a side view of the headgear strap of FIG. 27.

FIG. 33 shows a top view of the headgear strap of FIG. 27.

FIG. 34 shows a bottom view of the headgear strap of FIG. 27.

FIG. 35 shows a top view of an embodiment of a headgear strap.

DETAILED DESCRIPTION

The respiratory mask system of the preferred and alternative formsdescribed herein provides improvements in the delivery of CPAP therapy.In particular a respiratory mask system, is described which may provideimproved ease of use in relation to the fitment, sizing adjustment andassembly of the respiratory mask, when compared with the prior art. Itwill be appreciated that the respiratory mask as described can be usedin respiratory care generally or with a ventilator but will be describedfor illustration with reference to use in a humidified CPAP system. Itwill also be appreciated that the preferred and alternative formsdescribed can be applied to any form of respiratory mask including, butnot limited to, full face masks sealing around the patient's nose andmouth, and nasal masks sealing around the patient's nose.

With reference to FIG. 1 a humidified Continuous Positive AirwayPressure (CPAP) system is shown in which a patient 1 is receivinghumidified and pressurised breathable gases through a respiratory mask 2connected to a humidified gases transportation pathway or inspiratoryconduit 3. It should be understood that delivery systems could also beVPAP (Variable Positive Airway Pressure) and BiPAP (Bi-level PositiveAirway Pressure) or numerous other forms of respiratory therapy.

Inspiratory conduit 3 is connected to the outlet 4 of a humidificationchamber 5 which contains a volume of water 6. Inspiratory conduit 3 maycontain heating means or heater wires (not shown) which heat the wallsof the conduit to reduce condensation of humidified gases within theconduit. Humidification chamber 5 is preferably formed from a plasticsmaterial and may have a highly heat conductive base (for example analuminum base) which is in direct contact with a heater plate 7 ofhumidifier 8. Humidifier 8 is provided with control means or electroniccontroller 9 which may comprise a microprocessor based controllerexecuting computer software commands stored in associated memory.

Controller 9 receives input from sources such as a user input interfaceor dial 10 through which a user of the device may, for example, set apredetermined required value (pre-set value) of humidity or temperatureof the gases supplied to patient 1. The controller may also receiveinput from other sources, for example temperature and/or flow velocitysensors 11 and 12 through connector 13 and heater plate temperaturesensor 14. In response to the user set humidity or temperature valueinput via dial 10 and the other inputs, controller 9 determines when (orto what level) to energize heater plate 7 to heat the water 6 withinhumidification chamber 5. As the volume of water 6 within humidificationchamber 5 is heated, water vapour begins to fill the volume of thechamber above the water's surface and is passed out of thehumidification chamber 5 outlet 4 with the flow of gases (for exampleair) provided from a gases supply or blower 15 which enters the chamberthrough inlet 16. Exhaled gases from the patient's mouth are passeddirectly to ambient surroundings in FIG. 1.

Blower 15 is provided with a variable pressure regulator or with avariable speed fan 21 which draws air or other gases through blowerinlet 17. The speed of variable speed fan 21 is controlled by electroniccontroller 18 (or alternatively the function of controller 18 could becarried out by controller 9). The controller may control the fan speedor regulated pressure according to any useful criteria. For example thecontroller may respond to inputs from controller 9 and a user setpredetermined required value (pre-set value) of pressure or fan speedvia dial 19.

FIG. 2 shows a non-limiting exemplary embodiment of the respiratory masksystem 100 of the present disclosure, configured to provide a supply ofpressurized breathable gases to a patient's airway. The respiratory masksystem 100 comprises a frame 120, sealing cushion 140, headgear 160 anda forehead coupler 180.

As shown in FIG. 3 the frame 120 comprises a substantially triangularcomponent having two headgear connections 121 (forming the lower pointsof the triangle) and a forehead support 122 (forming the upper point ofthe triangle). The frame 120 further comprises a central gas inlet 123through which a supply of pressurized breathable gases can be deliveredto the patient's airways, and a sealing cushion connection 124 (notshown). The frame 120 is configured to act as an interfacing componentand connect the sealing cushion 140, headgear 160 and forehead coupler180 together.

The forehead support 122 comprises an elongate member that in useextends upwardly, away from the headgear connections, towards thepatient's forehead and terminates at a distal end 125. A couplerconnection 126 is located at the distal end. The coupler connection 126comprises an aperture 127 in the form of an elongate slot, wherein theside of the aperture that is closest to the distal end has an opening128 extending from it, such that the aperture is not fully enclosed. Theaperture 127 and opening 128 form a fork, having two prongs 129, in theforehead support 122. The opening 128 is configured to provide a narrowpath through which the forehead coupler 180 can be connected to thecoupler connection 126.

The sealing cushion 140 comprises an integrally formed seal housing 141and flexible cushion 142, as shown in FIG. 2. The seal housing 141 isconfigured to provide a substantially rigid breathing chamber about thepatient's nose and/or mouth and attach to the sealing cushion connection124 of the frame 120. The flexible cushion 142 is configured to engage apatient's face such that a substantially airtight seal is formed aboutthe patient's nose, mouth or nose and mouth. The flexible cushion 142can be made from silicone, thermoplastic elastomer or any otherappropriate material capable of at least partially conforming to thefacial geometry of the patient. The flexible cushion 142 comprises arolling bridge 143 located proximal to the patient's nasal bridge, inuse. The rolling bridge 143 is configured to allow an upper portion ofthe flexible cushion to roll during hinging movement of the upperportion relative to a lower portion of the flexible cushion, asdescribed in US2014/0096774A1, which is hereby incorporated by referenceherein in its entirety.

The headgear 160 is configured to extend around and retains therespiratory mask system 100 on the patient's head, in use. As shown inFIG. 4 the headgear comprises a rear portion 161, two side straps 162,two forehead straps 163 and two top straps 164. In alternativeembodiments there may be more or less side, forehead or top straps 162,163, or 164. The side, forehead and top straps 162, 163 and 164 all havea fixed end 165 and a free end 166. The side straps 162 and foreheadstraps 163 extend laterally from the fixed ends 165 that connect to therear portion 161, and the top straps 164 extend at an angle from theforehead straps 163. The side straps 162 connect to the headgearconnections 121 of the frame 120 via a clip 167 and the forehead straps163 connect to the forehead coupler 180. The top straps 164 areconfigured to pass over the top of a patient's head, in use, and areconnected together via a buckle 168. The size of the headgear can beadjusted by folding the side, forehead or top straps 162, 163, or 164back on themselves and securing the free ends 166 in place by means suchas, but not limited to, hook and loop fastener, clips or clasps. Thisallows the in-use length of each of the side, forehead or top strap 162,163, or 164 to be adjusted. As used herein the term “in-use length”shall mean the length of any of the side, forehead and/or top straps162, 163, and/or 164 between the fixed end 165 and the point at whichthey connect with another component such as the buckle 168, clip 167 orforehead coupler 180. In alternative embodiments there may be a singlefixed length top strap. The headgear can be made of a layered fabricsuch as Breath-o-prene™ or any other appropriate material, and may beelastic and/or inelastic.

The forehead coupler 180 is configured to removably couple the foreheadstraps 163 and frame 120 together. When coupled together, the foreheadstraps 163 and forehead coupler 180 form a closed loop that isconfigured to extend around the patient's head and across theirforehead, wherein the forehead coupler 180 is positioned near the centerof the patient's forehead. The forehead coupler 180 is configured suchthat when it is removed from the frame 120 the closed loop remainsintact. That is, the forehead coupler 180 allows a user to connect ordisconnect the top strap from the forehead support of the frame 120 in asingle action while still maintaining the loop tightnesssetting/connection of the top strap. This is beneficial as it allows thepatient to remove the respiratory mask system 100 without altering thefit of the forehead straps, which improves ease of use and may lead toimproved compliance with their therapy.

As shown in FIGS. 5A and 5B the forehead coupler 180 comprises a pair ofstrap connectors 181, a flexible linking member 182 and a frameconnector 183. The strap connectors 181 comprise a substantially rigidplastic component having first and second strap slots 184 and 185symmetrically separated by a central post 186. The strap slots aresubstantially rectangular in shape and are configured to receive astrap. The first strap slot 184 is configured to receive one of theforehead straps 163 and the second strap slot 185 is configured toreceive one end of the flexible linking member 182. The size of theclosed loop can be adjusted, to match the head circumference of thepatient, by adjusting the in-use length of the forehead straps 163, asdescribed above.

The flexible linking member 182 comprises a fabric strap having a firstend 187, second end 188 and central portion 189. The first and secondends 187 and 188 pass through the second strap slots 185 of the strapconnectors 181, and fold back over to be permanently secured to thecentral portion 189. The permanent securement can be achieved by meanssuch as, but not limited to, sewing, adhesive or welding. The centralportion 189 comprises the frame connector 183 as an integrally formedcomponent which is configured to be removably coupled to the couplerconnection 126 and allow the strap connectors 181 to flex independentlyof one another and the frame connector 183 in more than one direction.The fabric that the flexible linking member 182 is made of issubstantially inelastic, such that the size of the closed loop andheadgear 160 does not alter unintentionally during use. The flexibilityof the fabric allows the flexible linking member 182 and thus theforehead coupler 180 to twist and bend in order to conform to the shapeof the patient's forehead and provide a soft or cushioned interfacebetween the frame 120 and the patient. This may be advantageous inimproving the fit of the respiratory mask system 100 and the patient'scomfort. In alternative embodiments the flexible linking member 182 maybe made from a plastic film or strap that is flexible and substantiallyinelastic.

The forehead coupler 180 is configured to have a T-shaped profile asshown in FIG. 5B. The T-shaped profile comprises a stem 190 and a pairof arms 191. The stem 190 is formed by the frame connector 183 and thearms 191 are formed by the strap connectors which extend laterally fromthe stem 190.

The frame connector 183 is integrally formed in the central portion 189of the flexible linking member 182. It is formed by the flexible linkingmember 182 being folded in half and permanently joined between thefolded layers, to form a linking portion 193. The linking portion 193 isconfigured to pass through the opening of the coupler connection 126,and can be formed by means such as, but not limited to, welding, sewingor adhesives. Preferably the layers of fabric in the linking portion 193are compressed by the joining means, such that they are thinner and morerigid than the fabric of the flexible linking member 182, to enable thelinking portion 193 to pass easily through the opening 128 of thecoupler connection 126. The linking portion 193 is offset from thecrease of the fold, such that a loop 194 (also referred to as a headportion herein) is formed in the flexible linking member 182. The loop194 has a diameter that is greater than the width of the aperture 127 inthe coupler connection 126 of the frame 120 and may be filled with amaterial that reduces the compressibility of the loop 194, such that itcannot be pulled through the aperture 127.

The linking portion 193 forms a tongue or neck portion which isconfigured to join with the coupler connection 126 of the frame 120 in atongue and fork joint, as shown in FIG. 6. The prongs 129 of the couplerconnection 126 are configured to deflect when the linking portion 193passes between them. The width of the opening 128 is narrower than thethickness of the linking portion 193 such that there is a friction forcethat discourages the forehead coupler 180 from becoming unintentionallydetached from the frame 120.

In an alternative embodiment the strap connectors 181 may comprise onlya first strap slot 184, through which the forehead straps 163 areconnected. The strap connectors 181 can be permanently connected to thefirst and second ends 187 and 188 of the flexible linking member 182, bymeans such as, but not limited to, over-moulding, welding, adhesives orsewing.

FIG. 7 shows an alternative embodiment of the previously describedforehead coupler 180. The embodiment of FIG. 7 comprises a foreheadcoupler 280 having integrally formed strap connectors 281. The strapconnectors 281 comprise a plastic component that is over-moulded orwelded to the flexible linking member 282. A strap slot 284, throughwhich the forehead straps 163 pass, extends through both the strapconnector 281 and the flexible linking member 282. The strap connectors281 are configured to provide the flexible linking member 282 withstructure around the strap slots 284, such that it is easy to connectand adjust the in-use length of the forehead straps 163. The strapconnector 281 minimizes deformation of the strap slot 284 whilstreducing the overall bulk of the forehead coupler 280.

Another non-limiting exemplary embodiment of a forehead coupler 380 isshown in FIG. 8. The forehead coupler 380 comprises a strap connector381 and a flexible linking member 382, which are permanently joined. Theflexible linking member 382 comprises a frame connector 383, first andsecond ends 387 and 388 and a central portion 389. It is configured toprovide a flexible connection between the frame connector 383 and thestrap connector 381. The frame connector 383 is substantially the sameas described in relation to previous embodiments. The first and secondends 387 and 388 along with the central portion 389 are permanentlyconnected to the strap connector 381 by means such as, but not limitedto, over-moulding, welding or adhesives.

The strap connector comprises an elongate component having an innersurface 396 and an outer surface 397, and a strap slot 384 located ateach end. The inner surface 396 is configured to sit near or against thepatient's forehead in use; correspondingly the outer surface 397 isconfigured to be distal to the patient's forehead. The outer surface 397comprises a recess 398, which is configured to receive the first andsecond ends 387 and 388 and the central portion 389 of the flexiblelinking member 382, in a permanent connection as previously described.The strap connector 381 is made from a substantially inelastic plastic,which may or may not be flexible. When assembled in a respiratory masksystem 100 the forehead straps 163 are connected together in a closedloop by the forehead coupler 380. In an embodiment wherein the strapconnector 381 is made of an inflexible material, the ends of theforehead straps 163 are held in a fixed position relative to each otherbut are capable of flexing relative to the frame connector 383 and frame120. The strap slots 384 are configured to extend through both the strapconnector 381 and the flexible linking member 382.

FIGS. 9A, 9B and 9C show a further embodiment of a forehead coupler 480.The forehead coupler 480 comprises a strap connector 481 and a frameconnector 483, which are permanently attached to each other. The strapconnector 481 comprises a substantially rectangular buckle having a backside 496, front side 497 and a strap slot 484 on each lateral side,wherein the strap slots 484 are separated by a central post 489. Thefront side 497 is configured to sit away from the patient's forehead inuse, whereas the back side 496 is configured to contact or sit nearerthe patient's forehead. The strap slots 484 are configured to receivethe forehead straps 163 such that the in-use length is adjustable asdescribed in relation to previous embodiments. When viewed end-on alongthe length of the strap slots 484 the strap connector 481 is curved suchthat front side 497 is concave. On the back side 496 the central post489 comprises one or more rivets 498 configured to secure the frameconnector 483 to the strap connector 481.

The frame connector 483 comprises a loop made from a fabric strap thatis configured to extend around the central post 489, such that there isa gap between the front side 497 of the central post 489 and the insideof the frame connector 483. The ends of the strap are overlapped andsecured to the back side 496 of the strap connector 481 by the one ormore rivets 498. The ends of the fabric strap may comprise pilot holes(not shown) through which the rivets 498 pass before being deformed topermanently secure the frame connector 483 in place. In some embodimentsthe rivets 498 may be deformed by a welding process such that they fuseto the material of the frame connector 483. The frame connector 483 isconfigured to receive and retain a part of the forehead support 122 ofthe frame 120.

FIGS. 10A, 10B and 10C shows another variation of the embodiment ofFIGS. 9A, 9B and 9C, wherein the front side 497 of the strap connector481 is convex and the frame connector 483 is secured to the strapconnector 481 by means such as welding or over-moulding. The strapconnector 481 comprises first strap slots 484 and second strap slot 485,wherein the frame connector 483 is configured to pass through the secondstrap slot 485 before being secured to the strap connector 481.

FIGS. 11A, 11B and 11C show a further variation of the forehead coupler480 of FIGS. 9A, 9B and 9C. In this variation the strap connector 481comprises two halves which are configured to be repeatedly connected anddisconnected to each other. Each half of the strap connector 481comprises an elongate strap slot 484 configured to receive one of theforehead straps 163. The two halves of the strap connector 481 areconnected together by a button and hole type snap-fit fastener. It is tobe understood that in other embodiments other types of snap-fitfasteners may be used and/or the connection between the two halves maybe permanent. The frame connector 483 comprises a strap of fabric havingtwo ends, wherein each of the ends is permanently secured to one half ofthe strap connector 481. The frame connector 483 forms a loop when thetwo halves of the strap connector are joined together, such that theloop may receive and/or retain a part of the forehead support 122 of theframe 120.

The embodiments of FIGS. 7 through 11C have all been numberedcorresponding to the forehead coupler 180 of FIGS. 2 to 6, such thatlike features have had a value of 100 added to their reference numeral.For example in FIG. 5A the strap connector has a reference numeral of181 and in the embodiment of FIG. 7 the strap connector has a referencenumeral of 281. Features with reference numerals that share the last twodigits function in substantially the same way when assembled as a partof the respiratory mask system as a whole. FIGS. 12A and 12B have notbeen numbered strictly in this way. Only the forehead coupler as acomplete component has been numbered with reference to the embodiment ofFIGS. 2 to 6.

FIGS. 12A and 12B show yet another non-limiting exemplary embodiment ofa forehead coupler 580. Forehead coupler 580 comprises a substantiallyflat and rectangular sleeve 581; having two short edges 582 and two longedges 583. The sleeve 581is configured to receive and retain a part ofthe forehead support 122 of the frame 120. The sleeve 581 comprises afront layer 584, back layer 585 and two strap slots 586. The strap slots586 run parallel to and are proximal to the short edges 582. The frontand back layers 584 and 585 are joined together around the perimeter ofthe strap slots 586, such that the short edges 582 are joined togetherand the long edges 583 are open. The strap slots 586 extend through boththe front and back layers 584 and 585 and are configured to receive theforehead straps 163. The short edges 582 are joined together by anover-moulded slot liner 587, wherein the slot liner 587 comprises asubstantially rigid sheath that is configured to reinforce the structureof the strap slots 586. The slot liner 587 forms a lining around theperimeter of the strap slots 586 and extends through the front and backlayers 584 and 585 terminating, on both sides, in a lip 588 that extendsoutwardly from the perimeter of each of the strap slots 586. The slotliner 587 is made of a substantially rigid thermoplastic material suchthat when it is over-moulded onto the sleeve 581 the material bonds tothe material of the front and back layers 584 and 585.

The front and back layers 584 and 585 are made of a fabric having aflexibility that varies between planes. For example the fabric may bemore flexible in a direction that is substantially perpendicular to thethickness of the fabric, than in a direction that is parallel to thethickness. This may be beneficial in allowing the forehead coupler 580to conform to the facial geometry of a patient without bunching up inthe connection between the frame 120 and the forehead coupler 580.

The forehead couplers of FIGS. 9A to 12B are secured to the foreheadsupport 122 of the frame 120 with a different coupler connection 126relative to the embodiment of FIGS. 2 to 8. The embodiments of FIGS. 9Ato 12B are configured for use with a coupler connection that comprises amale component that connects to a female component formed by the frameconnectors 483 and 583 of the forehead couplers 480 and 580. FIGS. 13A,to 15B show several non-limiting exemplary embodiments of couplerconnections 600, 700 and 800 comprising a male component. Theembodiments of FIGS. 13A, 13B, 14A and 14B both comprise a hook 610 or710, wherein at least part of the hook 610, 710 is configured to passthough the frame connector 483 or the sleeve 581. In the embodiment ofFIGS. 13A and 13B the hook 610 is substantially similar to a pocket clipthat commonly forms part of a ballpoint pen, and comprises an elongateshank 611, a return arm 612 and a throat 613. The shank 611 is formed bythe forehead support 122 and is configured to extend around a bend 614where it transitions into the return arm 612. The shank 611 and thereturn arm 612 are spaced apart such that a throat 615 is formed betweenthem. The throat 615 comprises a narrow throat opening 616 at the endopposing the bend 614. The return arm 612 comprises an elongate memberthat is configured to be received and retained by the frame connector483 or the sleeve 581, such that a portion of the frame connector 483 orsleeve 581 sits within the throat 613. The throat opening 616 isconfigured to be narrower than the thickness of the fabric of the frameconnector 483 or sleeve 581, such that the return arm 612 flexes toallow the frame connector 483 or sleeve 581 to pass through the throatopening 616. The narrowness of the throat opening 616 serves to retainthe frame connector 483 or sleeve 581 in place once assembled. In usethe return arm 612 is positioned proximal to the patient's forehead andthe shank 611 is distal.

FIGS. 14A and 14B show another embodiment of the coupler connection 700which comprises a hook 710 and is similar to the embodiment of FIGS. 13Aand 13B. The hook 710 comprises a shank 711 and a return arm 712 beingconnected together by a bend 714. The shank 711 is formed by theforehead support 122 and is configured to be located proximal to thepatient's forehead in use. The return arm 712 is a short extension of abend 714, and is considerably shorter in this embodiment than in theembodiment of FIGS. 13A and 13B. The entire hook 710 is configured topass through the forehead connector 483 (or in some embodiments thesleeve 581) such that the shank 711 is positioned within the frameconnector 483 (or sleeve 581) and the bend 714 and return arm 712 extendover an edge of the fabric loop that forms the frame connector 483 (orfront layer 584 of the sleeve 581). The bend 714 and return arm 712 actas a stop that inhibits or preferably prevents the forehead coupler 483(or sleeve 581) from slipping off the end of the forehead support 122.

The coupler connection 800 of FIGS. 15A and 15B comprises a post 810with an end stop 820. The post comprises an extension of the foreheadsupport 122, which terminates in the end stop 820 and is configured tobe inserted into the frame connector 483. There is a lip 830 formedwhere the dimensions of the forehead support step-down and becomesmaller to form the post 810. The end stop 820 comprises a bulbous heador raised ridge around the end of the post 810. The lip 830 and end stop820 are configured to be larger than the frame connector 483, such thatthe frame connector 483 is retained in place between them.

FIGS. 16A and 16B show a non-limiting exemplary embodiment of a headgearto frame connection for the respiratory mask system 100, wherein aheadgear 900 comprises a forehead strap 910 which is removably attachedto the frame 920. The forehead strap 910 is configured to extend from arear portion (not shown) across a patient's forehead, and comprises apair of straps that are permanently connected at a central joint 930 toform a closed loop. The length of the forehead strap 910 is such thatthe closed loop will be larger than the patient's foreheadcircumference. The central joint 930 may be formed by any means known inthe industry, such as but not limited to sewing, welding or adhesives.In an alternative embodiment the forehead strap 910 may comprise asingle strap that extends from one side of the rear portion to theother, forming a closed loop without a central joint 930.

The frame 920 can be substantially the same as that of the Simplus™ asmade by Fisher & Paykel Healthcare Ltd. The frame 920 comprises acoupler connection 940 further comprising a substantially flat extensionof a forehead support 922 having a pair of lateral hooks 950 that definea pair of elongate strap slots 960. The strap slots 960 are configuredto receive the forehead strap 910, such that the forehead strap 910passes from a rear side 970 of the coupler connection 940 through thestrap slots 960, across a front side 980 of the coupler connection 940and back through the other strap slot 960. The excess length of theforehead strap 910 can be pulled through the strap slots 960 so that theforehead support 922 is suspended just off a patient's forehead by thethickness of the forehead strap 910. The excess length of the foreheadstrap 910 is then folded to one side on the front side 980 of thecoupler connection 940 and secured in place as shown in FIG. 16B. Theexcess length of the forehead strap 910 is secured in place by meanssuch as but not limited to a hook and loop fastener.

FIGS. 17A through 17E show various views of a non-limiting exemplaryembodiment of a forehead coupler 1000 that is configured to connect theforehead straps 163 of the headgear 160 together in a closed loop andconnect the headgear 160 to a frame 1001. The forehead coupler 1000comprises a substantially rigid buckle that has a butterfly-like shape,wherein the wings are formed by a pair of lateral strap connectors 1002and the body is formed by a frame connector 1003 that is configured tolink the strap connectors 1002 together. The frame connector 1003 isconfigured to connect to a coupler connection 1004 of a frame 1001 thatis substantially similar to the coupler connection 600 of FIGS. 13A and13B.

The strap connectors 1002 have a somewhat ‘D’ shaped profile andcomprise a strap aperture 1005; configured to receive the foreheadstraps 163 of the headgear 160, and a strap guide 1006 configured toalign the forehead straps 163. The strap apertures 1005 comprise anopening having a profile that is substantially ‘D’ shaped and offsetfrom the profile of the strap connectors 1002; wherein the straight edgeof the ‘D’ forms an inner edge 1007 of the strap guide 1006 and thecurved side defines the boundary between the strap connectors 1002 andthe frame connector 1003. The length of the inner edge 1007 issubstantially the same as the width of the forehead straps 163, suchthat the forehead straps 163 can pass through the strap aperture 1005.In some configurations there can be a tight fit between the foreheadstraps 163 and the strap apertures 1005. In such a configuration thefriction between the forehead straps 163 and the strap apertures 1005causes the forehead straps to be temporarily retained at a set in-uselength, when the free ends 166 are unsecured, until a force is appliedby a user that overcomes the frictional forces. This means that thein-use length will not change until an intentional force is applied,which can be advantageous during fitting and adjustment of therespiratory mask and headgear.

As shown in FIG. 17C the forehead coupler 1000 has a front side 1008 anda back side 1009, wherein the front side 1008 is configured to face awayfrom the patient's face, in use, and the back side 1009 is configured toface towards the patient's face. The strap guide 1006 comprises a flat,substantially rectangular portion that extends laterally from the inneredge 1007 formed by the strap apertures 1005. On the front side 1008 thestrap guide 1006 is recessed such that a lip 1010 is formed along eachof the edges of the strap guide 1006 that are perpendicular to the inneredge 1007. The lips 1010 are spaced apart by the length of the inneredge 1007. The lips are configured to locate and align the foreheadstraps 163 within the boundary of the forehead coupler 1000. The strapconnector 1002 is configured such that a forehead strap 163 passes alongthe back side 1009 of the strap guide 1006, through the strap aperture1005 and back over the front side 1008 of the strap guide 1006, beforebeing secured in place. The free end 166 of the forehead strap 163 issecured to the forehead strap by means described in relation to previousembodiments.

The frame connector 1003 comprises a crossbar 1011 and a rib slot 1012.With reference to the view shown in FIG. 17B, the crossbar 1011comprises a solid beam that extends horizontally between the lowerhalves of the strap connectors 1002. It is configured to be received bythe coupler connection 1004 of the frame 1001.The upper halves of thestrap connectors 1002 are not connected and form the rib slot 1012. Therib slot 1012 comprises a gap between strap connectors 1002 having wallsthat are substantially perpendicular to the crossbar 1011 and curveoutwardly in an upward direction from the crossbar 1011. The outwardcurvature of the walls of the rib slot 1012 provides a wide and smoothopening to guide the rib 1023 into the rib slot 1012, which allows theforehead coupler 1000 to be more easily aligned and connected to thecoupler connection 1004 of the frame 1001. The rib slot 1012 isconfigured to engage with a corresponding rib that forms a part of thecoupler connection 1004.

As shown in FIG. 17D, the crossbar 1011 has a cross-sectional profilecomprising a first end 1013 and a second end 1014 being connected by twoflat sides 1015, wherein the first and second ends 1013 and 1014 havesemicircular profiles. The diameter of the first end 1013 is smallerthan the diameter of the second end 1014 such that the crossbar 1011 isasymmetrical from end-to-end and thus an acute angle is formed betweenthe two flat sides 1015. The smaller diameter of the first end 1013 andthe angled flat sides 1015 provide a lead in that reduces the forcerequired to engage the frame connector 1003 with the coupler connection1004. The length of the flat sides 1015 is greater than the diameter ofthe second end 1014, which reduces rotation (i.e., about the first endand second end) and provides stability in the connection between theframe connector 1003 and the coupler connection 1004.

When viewed from above, as in FIG. 17C, it can be seen that the frameconnector 1003 is offset from the strap connectors 1002, by a distanceO. This reduces or minimizes the chances of the frame 1001 coming intocontact with a patient's forehead during use, as the offset is greaterthan the depth of the coupler connection D.

The coupler connection 1004 is substantially similar to the couplerconnection 600 of FIG. 13A. As shown in FIGS. 17D and 17E, it comprisesa hook 1016 having a shank 1017 that extends approximately 180° around abend 1018 and into a return arm 1019, wherein a throat 1020 is formedbetween the shank 1017 and the return arm 1019. The return arm 1019comprises a bump 1021 at the end opposing the bend 1018, wherein theapex of the bump 1021 forms a throat opening 1022 that is narrower thanthe throat 1020. The apex of the bump 1021 is offset from the end of thereturn arm 1019 such that the bump 1021 has a lower surface 1025 that isangled towards the shank 1017 in an upwards direction. The lower surface1025 forms a lead in which improves alignment of the crossbar 1011 withthe throat opening 1022 and thus improves the ease with which theforehead coupler 1000 can be assembled to the coupler connection 1004.The outwardly curving walls of the rib slot 1012 also aid in aligningthe frame connector 1003 with the throat opening 1022, during assemblyof the forehead coupler 1000 and the frame 1001 by avoiding interferencebetween the bend 1018 of the hook 1016 and the strap connectors 1002.

The throat 1020 is configured to receive the crossbar 1011 of the frameconnector 1003. The return arm 1019 is configured to flex away from theshank 1017, about the bend 1018, such that the crossbar 1011 may passthrough the throat opening 1022, which is narrower than the diameter ofboth the first and second ends 1013 and 1014 of the crossbar 1011. Aninterference fit between the crossbar 1011 of the forehead coupler 1000and the frame 1001 (i.e., the crossbar 1011 and the return arm 1019)reduces slop or free-play in the joint to inhibit or prevent the frame1001 from moving or rotating relative to the crossbar 1011. Further, theinterference fit also provides an audible ‘click’ noise when theforehead coupler 1000 and the frame 1001 are connected together. Theaudible ‘click’ noise provides positive feedback for the user so thatthey know the forehead coupler 1000 and the frame 1001 are properlyconnected.

The hook 1016 further comprises a rib 1023, which is an elongatesubstantially rectangular extrusion that extends between the shank 1017and the return arm 1019 such that the throat 1020 is filled in at theend that is proximal to the bend 1018. The rib is configured to inhibitor preferably prevent the forehead coupler 1000 from being connected tothe coupler connection 1004 in the wrong orientation, and increases thestrength of the hook 1016 and reduces the likelihood of the return arm1019 being broken away from the shank 1017. The rib 1023 also improvesthe stability of the connection between the forehead coupler 1000 andthe coupler connection 1004, by engaging with the rib slot 1012 of theframe connector 1003. In other words, the rib 1023 contacts thesidewalls of the rib slot 1012 which prevent or inhibit rotation of theframe connector 1003 around the rib 1023. The rib 1023 is configured tobe substantially the same width as the portion of the rib slot 1012 thatis perpendicular to the crossbar 1011 and have a substantially narrowerwidth than the return arm 1019 and bump 1021. This at leastsubstantially inhibits or preferably prevents the crossbar 1011 frombeing inserted into the throat 1020 in the wrong orientation.

FIGS. 18A through 18G show various views of another non-limitingembodiment of a forehead coupler 1100 that is substantially similar tothe forehead coupler 1000. The forehead coupler 1100 is configured toconnect the forehead straps 163 of the headgear 160 together in a closedloop and connect the headgear 160 to a frame 1101. The forehead coupler1100 comprises a substantially rigid buckle that has a butterfly-likeshape, wherein the wings are formed by a pair of lateral strapconnectors 1102 and the body is formed by a frame connector 1103 that isconfigured to link the strap connectors 1102 together. The frameconnector 1103 is configured to connect to a coupler connection 1104 ofa frame 1101 that is substantially similar to the coupler connection 600of FIGS. 13A and 13B.

As shown in FIGS. 18A and 18B, the strap connectors 1102 aresubstantially similar to the strap connectors 1002, and comprise a strapaperture 1105 and a strap guide 1106. The forehead coupler 1100 has afront side 1108 and a back side 1109, wherein the front side 1108 isconfigured to face away from the patient's face, in use, and the backside 1109 is configured to face towards the patient's face. The frameconnector 1103 is similar to frame connector 1003 in that it comprises acrossbar 1111 and a rib slot 1112. In this embodiment, the crossbar 1111comprises a cylindrical beam that extends between the lower halves ofthe two strap connectors 1102. The rib slot 1112 is formed within a thinflange 1113 that extends upwardly (as viewed in FIG. 18B) from thecrossbar 1111 and extends between the two strap connectors 1102. Asshown in FIG. 18c , the flange 1113 extends tangentially from the backside 1109 of the crossbar 1111 and has a thickness T that is less thanthe radius of the crossbar 1111, thus creating a recess 1114 on thefront side 1108 of the frame connector 1103. The rib slot 1112 comprisesa cut out in the flange 1113 that is substantially the same shape as ribslot 1012. As based on the view of FIG. 18B, the rib slot 1112 comprisestwo substantially vertical long edges 1115 separated by a horizontalshort edge 1116. The short edge 1116 runs parallel with the crossbar1111. The two long edges 1115 extend perpendicularly from the ends ofthe short edge 1116 and curve outwardly in an upwards direction. Theoutward curvature of the two long edges 1115 provides a wide and smoothopening to guide the rib 1117 into the rib slot 1112, which allows theforehead coupler 1100 to be more easily aligned and connected to thecoupler connection 1104 of the frame 1101. The rib slot 1112 isconfigured to engage with a corresponding rib 1117 that forms a part ofthe coupler connection 1104. The rib 1117 and rib slot 1112 improve thestability of the connection between the forehead coupler 1100 and thecoupler connection 1104. In other words, the rib 1117 contacts the twolong edges 1115 of the rib slot 1112. The contact prevents or inhibitsrotation of the frame connector 1103 around the rib 1117.

The coupler connection 1104 is substantially similar to the couplerconnection 1004 of FIGS. 17A to 17E. It comprises a hook 1118 having ashank 1119 that extends approximately 360° around a bend 1120 and into areturn arm 1121, wherein a throat 1122 is formed between the shank 1119and the return arm 1121. The return arm 1121 comprises an internalsurface 1123 and an external surface 1124, wherein the external surface1124 is convexly curved. The external surface 1124 terminates and meetsthe internal surface 1123 at point which forms a free end 1125 at theend opposing the bend 1120. A throat opening 1126 is formed between thefree end 1125 and the shank 1119, wherein the throat opening 1126 isnarrower than the throat 1122. The throat opening 1126 is configured tobe narrower than the radius of the crossbar 1111 in order to inhibit orpreferably prevent incorrect assembly of the forehead coupler 1100 tothe coupler connection 1104, as shown in FIGS. 18D to 18G. The hook 1118further comprises a rib 1117, which is substantially the same as the rib1023 of the previous embodiment shown in FIG. 17E.

FIG. 18D shows the only orientation that allows for a complete andcorrect assembly between the forehead coupler 1100 and the couplerconnection 1104. The forehead coupler must be oriented with the flange1113 above the crossbar 1111 and the recess 1114 proximal to the shank1119. It can be seen that the flange 1113 enters the throat opening 1126first and forms a wedge that forces the return arm 1121 to flex awayfrom the shank 1119 such that the crossbar 1111 can pass through thethroat opening 1126. FIG. 18E shows that forehead coupler 1100preferably cannot be assembled with the coupler connection 1104 whenoriented with the flange 1113 above the crossbar 1111 and the recess1114 proximal to the return arm 1121. This is because the point of thefree end 1125 engages with the recess 1114 such that the crossbar 1111acts as a stop. The thickness of the flange 1113 being less than theradius of the crossbar 1111 means that the engagement of the free end1125 with crossbar 1111 at the base of the recess 1114 does not resultin the return arm 1121 flexing away from the shank 1119, and thus thecrossbar 1111 preferably cannot pass through the throat opening 1126.

FIGS. 18F and 18G show the forehead coupler 1100 in two moreorientations that will not allow it to be assembled with the couplerconnection 1104. The forehead coupler is oriented with the crossbar 1111above the flange 1113 in both configurations. Since the throat opening1126 is narrower than the radius of the crossbar 1111 the point of thefree end 1125 engage with the crossbar 1111 in such a way that thecrossbar 1111 cannot generate any leverage to flex the return arm 1121away from the shank 1119. As the return arm 1121 is not flexed away fromthe shank 1119 the throat opening 1126 is not enlarged such that thecrossbar 1111 cannot pass through. For forehead couplers 1000, 1100 thatare substantially rigid, it is advantageous that they can only beassembled to the coupler connection 1004, 1104 in one orientation. Thisis because it reduces the likelihood of a user assembling the maskincorrectly, which may reduce the efficacy of therapy provided to thepatient.

FIGS. 19A to 19E show a range of views of a further non-limitingexemplary embodiment of a forehead coupler 1200, which is similar inconfiguration to forehead couplers 1000 and 1100. The forehead coupler1200 is configured to connect to a coupler connection 600, substantiallyas described in relation to FIGS. 13A and 13B. Forehead coupler 1200comprises a pair of strap connectors 1201 that are connected together bya frame connector 1202. The strap connector comprises a strap aperture1203 through which the forehead straps 163 of headgear 160 areconfigured to pass.

The frame connector 1202 is formed by a solid portion between the twostrap apertures 1203. As shown in FIG. 19C, the frame connector 1202 isoffset from the forehead strap connectors 1201, such that when assembledto the coupler connection 600 the strap connectors are substantiallyflush with the return arm 612. This configuration will preferablyprevent the return arm 612 from contacting the patient's forehead duringuse, as the forehead straps 163 will form a cushioning layer between thestrap connectors 1201 and the patient's forehead. As shown in FIG. 19Dthe frame connector has an elongate cross-sectional profile comprising acircular lower end 1204 and a wedge shaped upper end 1205. The wedgeshaped upper end 1205 is configured to act as a lead in that passesthrough the throat opening 616 and flex the return arm 612 away from theshank 611 such that the throat opening 616 is enlarged and the lower end1204 can pass through. The circular cross-section of the lower end 1204has a diameter that is greater than the width of the throat opening 616.This configuration provides a snap fit connection that retains the frameconnector 1202 within the coupler connection 600.

As shown in FIG. 19B, the strap connectors 1201 extend beyond the upperend 1205 of the frame connector 1202, which results in the bend 614 ofthe coupler connection 600 being substantially flush with the upper endsof the strap connectors, in use. This may improve the aesthetics of themask. The length L (as shown in FIG. 19D) of the frame connector 1202improves the rotational stability of the connection between the couplerconnection 600 and the forehead coupler 1200.

FIGS. 20A to 20I illustrate a range of views of an alternative frameconnector and coupler connection arrangement for connecting a foreheadcoupler 1300 to a frame 1301. The forehead coupler 1300 is configured toconnect the forehead straps 163 of the headgear 160 together in a closedloop and connect the headgear 160 to the frame 1301. As shown in FIGS.20A and 20B, the forehead coupler 1300 comprises a substantially rigidbuckle that has a butterfly-like shape, wherein the wings are formed bya pair of lateral strap connectors 1302 and the body is formed by aframe connector 1303 that is configured to link the strap connectors1302 together. The frame connector 1303 is configured to connect to acoupler connection 1304 of the frame 1301 that is substantially similarto the coupler connection 600 of FIGS. 13A and 13B.

As shown in FIGS. 20A and 20B, the strap connectors 1302 aresubstantially similar to the strap connectors 1002, 1102 and comprise astrap aperture 1305 and a strap guide 1306. The forehead coupler 1300has a front side 1308 and a back side 1309, wherein the front side 1308is configured to face away from the patient's face, in use, and the backside 1309 is configured to face towards the patient's face. The frameconnector 1303 is similar to frame connectors 1003, 1103 in that theframe connector 1303 comprises a crossbar 1311 similar to the crossbar1011 and a rib slot 1312 similar to the rib slot 1112.

Similar to the crossbar 1011, the crossbar 1311 has a cross-sectionalprofile comprising a first end 1333 and a second end 1334 beingconnected by two flat sides 1335, wherein the first and second ends1333, 1334 have semicircular profiles. The diameter of the first end1333 is smaller than the diameter of the second end 1334 and thus anacute angle is formed between the two flat sides 1335. The smallerdiameter of the first end 1333 and the angled flat sides 1335 reducesthe force required to engage the frame connector 1303 with the couplerconnection 1304. The length of the flat sides 1335 is greater than thediameter of the second end 1334, which reduces rotation (i.e., about thefirst end and second end) and provides stability in the connectionbetween the frame connector 1303 and the coupler connection 1304.Similar to the frame connector 1003 in FIG. 17C, the frame connector1303 is offset from the strap connectors 1302, as shown in FIG. 20F.This reduces or minimizes the chances of the frame 1301 coming intocontact with a patient's forehead during use.

Similar to the rib slot 1112, the rib slot 1312 is formed within a thinflange 1313 that extends upwardly (as viewed in FIG. 20C) from thecrossbar 1311 and extends between the two strap connectors 1302. Asshown in FIG. 20E, the flange 1313 extends tangentially from the backside 1309 of the crossbar 1311 and has a thickness T that is less thanthe radius of the crossbar 1311, thus creating a recess 1314 on thefront side 1308 of the frame connector 1303. The recess 1314 is similarto recess 1114 in FIGS. 18A to 18G. More specifically, the free end 1325of the return arm 1319 engages the recess 1314 to prevent connection ofthe forehead coupler 1100 and the coupler connection 1104 in only oneorientation. That is, similar to FIG. 18D, when the forehead coupler1300 is inserted into the coupler connection 1304 with the recess 1314facing away from the free end 1325 of the return arm 1319, the flange1313 enters the throat opening 1322 first and forms a wedge that forcesthe return arm 1319 to flex away from the shank 1317 such that thecrossbar 1311 can pass through the throat opening 1322. However, similarto FIG. 18E, when the forehead coupler 1300 is inserted into the couplerconnection 1304 with the recess 1314 facing the free end 1325 of thereturn arm 1319, the free end 1325 engages with the recess 1314 suchthat the crossbar 1311 acts as a stop. The thickness of the flange 1313being less than the radius of the crossbar 1311 means that theengagement of the free end 1325 with crossbar 1311 at the base of therecess 1314 does not result in the return arm 1319 flexing away from theshank 1317, and thus the crossbar 1311 preferably cannot pass throughthe throat opening 1322.

The rib slot 1312 comprises a cut out in the flange 1313 that issubstantially the same shape as rib slot 1012, 1112. As based on theview of FIGS. 20B to 20D, the rib slot 1312 comprises two substantiallyvertical long edges 1315 separated by a horizontal short edge 1316. Theshort edge 1316 runs parallel with the crossbar 1311. The two long edges1315 extend perpendicularly from the ends of the short edge 1316 andcurve outwardly in an upwards direction. The outward curvature of thetwo long edges 1315 provides a wide and smooth opening to guide the rib1323 into the rib slot 1312, which allows the forehead coupler 1300 tobe more easily aligned and connected to the coupler connection 1304 ofthe frame 1301. The rib slot 1312 is configured to engage with acorresponding rib 1323 that forms a part of the coupler connection 1304.

As shown in FIGS. 20G to 20K, the coupler connection 1304 of the frame1301 is similar in configuration to the coupler connections 1004 and1104. That is, similar to the coupler connections 1004 and 1104, thecoupler connection 1304 comprises a hook having a shank 1317 thatextends approximately 180° around a bend 1318 and into a return arm1319, wherein a throat 1320 is formed between the shank 1317 and thereturn arm 1319. Further, the hook comprises a rib 1323, which is anelongate substantially rectangular extrusion that extends away from theshank 1317 towards the return arm 1319. Similar to the couplerconnections 1004 and 1104, in operation, the throat 1320 is configuredto receive the crossbar 1311 of the frame connector 1303. The return arm1319 is configured to flex away from the shank 1317, about the bend1318, such that the crossbar 1011 may pass through the throat opening1322, which is narrower than the diameter of both the first and secondends 1313 and 1314 of the crossbar 1311. When the crossbar 1311 ispositioned within the throat 1320, the rib 1323 is positioned within therib slot 1312, which improves the stability of the connection betweenthe forehead coupler 1300 and the coupler connection 1304. In otherwords, the rib 1323 is seated in the rib slot 1312 such that the rib1323 contacts the two long edges 1315 of the rib slot 1312 and preventsor inhibits rotation of the frame connector 1303 within the throat 1320.That is, the contact between the sides of the rib 1323 and the two longedges 1315 of the rib slot 1312 obstructs rotation of the frameconnector 1303 relative to the frame 1301. The rib 1323 is configured tobe substantially the same width as the portion of the rib slot 1312 thatis perpendicular to the crossbar 1311 and have a substantially narrowerwidth than the return arm 1319 and the bump 1321. This at leastsubstantially inhibits or preferably prevents the crossbar 1311 frombeing inserted into the throat 1320 in the wrong orientation. Further,an interference fit between the crossbar 1311 of the forehead coupler1300 and the frame 1301 (i.e., the shank 1317 and the return arm 1319)reduces slop or free-play in the joint to prevent the frame 1301 frommoving or rotating relative to the crossbar 1311. Further, theinterference fit also provides an audible ‘click’ noise when theforehead coupler 1300 and the frame 1301 are connected together. Theaudible ‘click’ noise provides positive feedback for the user so thatthey know the forehead coupler 1300 and the frame 1301 are properlyconnected.

In contrast to the coupler connections 1004, 1104, the rib 1323 of thecoupler connection 1304 is separated from the return arm 1319 by a gap1328 (as shown in FIG. 20I) whereas the ribs 1023, 1117 extend all theway through the throat 1020, 1122 from the shank 1017, 1119 to thereturn arm 1019, 1121. Separating the rib 1323 from the return arm 1319allows the entire length of the return arm 1319 to flex at the bend1318. As such, the force required to widen the throat opening 1322decreases, compared to the return arms 1019, 1121 having attached ribs1023, 1117. As a result, the force required to insert the frameconnector 1303 into the frame 1301 decreases (i.e., the effort requiredto connect and disconnect the forehead coupler 1300 to the frame 1301decreases), which makes donning and removing the headgear easier. Thebend 1318 may have a shape and/or thickness that reduces the stresseswithin the bend 1318 such that the return arm 1319 will not fracture orinelastically (plastically) deform. Further, the gap 1328 (i.e., thedistance between the rib 1323 and the return arm 1319) may have a widththat is substantially similar to the width of the throat opening 1322.Similarly, the gap 1328 and the throat opening 1322 is configured to benarrower than the thickness of the fabric of the forehead straps 163 ofthe headgear 160 such that the forehead straps 163 may not be mistakenlypositioned within the gap 1328. That is, the gap 1328 is too narrow forthe forehead straps 163 to be inserted within the gap 1328. As a result,by preventing the forehead straps 163 from being inserted within the gap1328, the user may not mistakenly assume that the forehead straps 163are properly attached to the frame 1301 (i.e., the forehead straps 163being attached directly to the frame 1301 without using the frameconnector 1303). In some configurations, the throat opening 1322 has awidth W of 1.45 mm, as illustrated in FIG. 20K.

Similar to the return arms 1019, 1121, the return arm 1319 comprises abump 1321 at the end opposing the bend 1318, wherein the apex of thebump 1321 forms a throat opening 1322 that is narrower than the throat1320. The apex of the bump 1321 is offset from the end of the return arm1319 such that the bump 1321 has a surface 1326 that is angled towardsthe shank 1317 such that the throat opening 1322 narrows in a directiontoward the end of the return arm 1319. As illustrated in FIG. 20K, thebump 1321 may be rounded by a fillet having a radius R. Rounding thebump 1321 removes sharp edges that may prevent the throat opening 1322from widening to allow the crossbar 1311 from passing through the throatopening 1322. Accordingly, the force required to remove the foreheadcoupler 1300 from the frame 1301 decreases which improves usability ofthe headgear. In some configurations, the bump 1321 may have a radius Rof 2 mm Even further, in some configurations, the semicircular secondend 1334 of the crossbar 1311 may have a diameter D of 5.35 mm Thesecond end 1334 of the crossbar 1311 with a diameter D may contact thebump 1321 with a radius R to provide smooth and gradual widening of thethroat 1320 as the crossbar 1311 initially passes through the throatopening 1322.

Similar to the crossbar 1111 in FIGS. 18F and 18G, the diameter D of thesemicircular second end 1334 of the crossbar 1311 may be greater thantwice the width W of the throat opening 1322 such that the crossbar 1311may not be inserted into the throat opening 1322 in any orientationleading with the second end 1334 (i.e., the second end 1334 insertedinto the throat opening 1322 prior to the first end 1333). The throatopening 1322 is narrower than the radius of the crossbar 1311 and a freeend 1325 of the return arm 1319 engages the second end 1334 of thecrossbar 1311 in such a way that the crossbar 1311 cannot generate anyleverage to flex the return arm 1319 away from the shank 1317. As thereturn arm 1319 is not flexed away from the shank 1317, the throatopening 1322 is not enlarged such that the crossbar 1311 cannot passthrough and be inserted into the throat 1320.

As a result of the asymmetric shape and configuration of the foreheadcoupler 1300, the forehead coupler 1300 may be connected to the couplerconnection 1304 of the frame 1301 in only one of four possibleorientations. That is, the recess 1314 and the crossbar 1311 allow theforehead coupler 1300 to be inserted into the throat 1320 in only theorientation in which the flange 1313 is leading and the recess 1314faces away from the free end 1325 of the return arm 1319. In otherwords, the forehead coupler 1300 cannot be inserted into the throat 1320in an orientation in which the flange 1313 is leading and the recess1314 faces the free end 1325 of the return arm 1319, an orientation inwhich the second end 1334 is leading and the recess 1314 faces away fromthe free end 1325, and an orientation in which the second end 1334 isleading and the recess 1314 faces the free end 1325. As such, the useris inhibited or prevented from inserting the forehead coupler 1300 intothe coupler connection 1304 inside out, backwards, or backwards andinside out.

In some arrangements, a universal frame may be used with sealingcushions of different sizes. That is, the same frame may be fitted tosmaller-sized sealing cushions and medium- to larger-sized sealingcushions. Accordingly, the frame must accommodate various sized sealingcushions which are centred on the gas inlet of the frame. Even further,the frame must provide a range of size adjustability to accommodate eachsealing cushion size to ensure proper fitment (i.e., comfort andsealability) for users of different sizes. One particular type of sizeadjustment is the positioning of the forehead straps relative to thesealing cushion and the frame. For smaller users utilizing asmaller-sized sealing cushion, proper fitment may require the foreheadstraps to be positioned closer to the sealing cushion compared to alarger user utilizing a medium- to larger-sized sealing cushion. Inother words, having the forehead straps in the same position on auniversal frame for all sealing cushion sizes may be result in poorfitment for some users. Therefore, it may be necessary for the foreheadstraps to connect to the frame at a lower location for sealing cushionsof smaller sizes (i.e., relative to medium/larger sizes), in order toensure that the connection between the forehead straps and the frame isnot positioned too high on the user's forehead.

Accordingly, FIGS. 21A to 21C illustrate a universal frame 1301connected to interchangeable forehead couplers 1300 _(S), 1300 _(M/L) toaccommodate sealing cushions of various sizes. More specifically, theframe 1301 may be connected to the small forehead coupler 1300 _(S) foruse with smaller sealing cushion sizes and the medium/large foreheadcoupler 1300 _(M/L), for medium to larger sealing cushion sizes. Thesmall forehead coupler 1300 _(S) is configured to position the foreheadstraps of a headgear at a lower position relative to the frame 1301 andthe sealing cushion compared to the medium/large forehead coupler 1300_(M/L). As such, the small forehead coupler 1300 _(S) and themedium/large forehead coupler 1300 _(M/L), are substantially identicalexcept that the strap apertures 1305 _(S) are positioned lower on thesmall forehead coupler 1300 _(S) than on the medium/large foreheadcoupler 1300 _(M/L). In other words, as illustrated in FIGS. 22A to 25B,the size, shape, and geometries of the strap apertures 1305 _(S), 1305_(M/L), the crossbar 1311, the rib slot 1312, the flange 1313, and therecess 1314 are identical between the forehead coupler 1300 _(S), 1300_(M/L), such that both the forehead coupler 1300 _(S), 1300 _(M/L) maybe used interchangeably with the frame 1301. In FIGS. 21A and 21B, boththe strap apertures 1305 _(S), 1305 _(M/L) are illustrated as having anidentical height H. However, the position of the strap apertures 1305_(S), 1305 _(M/L) relative to the crossbar 1311, the rib slot 1312, theflange 1313, and the recess 1314 differs between the small foreheadcoupler 1300 _(S) and the medium/large forehead coupler 1300 _(M/L).More specifically, the strap apertures 1305 _(S) of the small foreheadcoupler 1300 _(S) are vertically offset by the offset distance O_(CB)from the crossbar 1311, the rib slot 1312, the flange 1313, and therecess 1314 compared to their comparative positions on the medium/largeforehead coupler 1300 _(M/L). Put another way, the strap apertures 1305_(S) of the small forehead coupler 1300 _(S) are positioned lowerrelative to the frame 1301 and the sealing cushion compared to the strapapertures 1305 _(M/L) of the medium/large forehead coupler 1300 _(M/L)by vertically offsetting the strap apertures 1305 _(S) from the crossbar1311 by the offset distance O_(CB). Accordingly, when the frame 1301 isfitted with a smaller-sized sealing cushion, the small forehead coupler1300 _(S) positions the forehead straps of the headgear lower relativeto the frame 1301 than the medium/large forehead coupler 1300 _(M/L).

FIGS. 22A to 25B show various views of the small forehead coupler 1300_(S) and the medium/large forehead coupler 1300 _(M/L) side-by-side forthe sake of comparison. As illustrated, the crossbar 1311, the rib slots1312, the flanges 1313, and the recesses 1314, are identical between theforehead coupler 1300 _(S) and the forehead coupler 1300 _(M/L) and onlyvary with respect to their positions relative to the strap apertures1305 _(S), 1305 _(M/L). Providing identical crossbars 1311, rib slots1312, flanges 1313, and recesses 1314 provides identical connectionstructure for connecting to the frame 1301 between the forehead couplers1300 _(S), 1300 _(M/L) which allows interchangeability between theforehead couplers 1300 _(S), 1300 _(M/L).

As shown in FIGS. 25A and 25B, the crossbar 1311 and the flanges 1313have a combined vertical length L on both the small forehead coupler1300 _(S) and the medium/large forehead coupler 1300 _(M/L). Thecombined vertical length L is identical on both the small foreheadcoupler 1300 _(S) and the medium/large forehead coupler 1300 _(M/L).Further, in FIG. 25A, a distance X is measured from a lowermost edge ofthe crossbar 1311, which is also the lowermost edge of the medium/largeforehead coupler 1300 _(M/L) , to the uppermost inner wall portion 1340_(M/L), of the strap apertures 1305 _(M/L). Similarly, in FIG. 25B, thedistance X is measured from the lowermost edge of the small foreheadcoupler 1300 _(S) to the uppermost inner wall portion 1340 _(S) of thestrap apertures 1305 _(S). The distance X is substantially identical onboth the small forehead coupler 1300 _(S) and the medium/large foreheadcoupler 1300 _(M/L). However, the small forehead coupler 1300 _(S)differs from the medium/large forehead coupler 1300 _(M/L) in that thecrossbar 1311 and the flanges 1313 on the small forehead coupler 1300_(S) are offset vertically upwards by the offset distance O_(CB)compared to the medium/large forehead coupler 1300 _(M/L). That is, thecrossbar 1311 and the flanges 1313 are shifted vertically upwards by theoffset distance O_(CB) on the small forehead coupler 1300 _(S). As aresult, when the small forehead coupler 1300 _(S) is attached to theframe 1301, the apertures 1305 _(S) will be positioned lower on theframe 1301 than the apertures 1305 _(M/L) when the medium/large foreheadcoupler 1300 _(M/L) is attached to the frame 1301. Preferably, theoffset distance O_(CB) is approximately 5 mm That is, the apertures 1305_(S) are preferably positioned approximately 5 mm lower than theapertures 1305 _(M/L). However, it should be understood to one ofordinary skill in the art that the offset distance may depend upon thevariance in size between small and medium/large mask sizes. Further, itshould be understood to one of ordinary skill in the art that thedistance X is measured from the uppermost inner wall portion 1340 _(S),1340 _(M/L) of the strap apertures 1305 _(S), 1305 _(M/L) because theframe 1301 and the forehead couplers 1300 _(S), 1300 _(M/L) aresuspended and held by the forehead straps along the uppermost inner wallportion 1340 _(S), 1340 _(M/L), of the strap apertures 1305 _(S), 1305_(M/L). In other words, the position of the uppermost inner wall portion1340 _(S), 1340 _(M/L) of the strap apertures 1305 _(S), 1305 _(M/L)relative to the crossbar 1311 (i.e., or any other frame connectorassembly) is generally determinative of the position of the foreheadstraps relative to the frame 1301 since the forehead couplers 1300 _(S),1300 _(M/L), are suspended by the forehead straps by the uppermost innerwall portion 1340 _(S), 1340 _(M/L), of the strap apertures 1305 _(S),1305 _(M/L). Even further, it should be understood to one of ordinaryskill in the art that the combined vertical length L and the distance Xare used to describe the comparative positions of the crossbar 1311relative to the strap apertures 1305 _(S), 1305 _(M/L). Varying of theposition of the crossbar 1311 relative to the strap apertures 1305 _(S),1305 _(M/L) allows the position of the strap apertures 1305 _(S), 1305_(M/L) to vary between the forehead couplers 1300 _(S), 1300 _(M/L),while still providing interchangeability of the forehead couplers 1300_(S), 1300 _(M/L).

Some respiratory masks have headgear to secure them to a patient's face.The headgear often includes adjustable straps for adjusting the size ofthe headgear to match a range of patient head sizes. A crown strap caninclude two strap portions that are joined together by a buckle at acentrally located point on the top of a patients head. FIG. 26 shows aperspective view of a prior respiratory mask 2100 comprising a mask body2104 and headgear 2106. While a nasal mask is shown, the presentlydisclosed subject matter is applicable to other mask types, such asnasal pillows, full face, and under nose. The headgear 2106 isconfigured to provide a means of easily connecting and disconnecting atleast a portion of the headgear 2106 to the mask body 2104. The headgear2106 includes a top strap or crown strap 2110 and a buckle member 2112.The buckle 2112 can be arranged to couple two portions of the crownstrap 2110. Each of the portions of the crown strap 2110 preferably hasan end portion 2114 and the end portion 2114 can have a coupling membersuch as a hook and loop fastener. The strap portions are threadedthrough at least one aperture in the buckle 2112 and folded back onthemselves before being secured in place. The strap portions are usuallysecured in place by a hook and loop fastener (such as VELCRO®) at theend portions 2114. There is a tab portion at the end portions 2114 thatcomprises the hook component of the fastener that is configured toattach to the material of the strap portion, which forms the loopcomponent of the fastener.

FIGS. 27-34 illustrate an embodiment of a headgear adjustment andconnection system that includes a pair of straps that are configured tobe linked together such that their combined length is incrementallyadjustable. The disclosed embodiments can be used with a crown strap,other straps (such as upper and lower mask attachment straps), or anyother headgear component. For example, the system can be utilized in thecrown strap of a headgear for an interface. The portions of the headgearand/or interface can be the same as or similar to the headgear andinterface assembly shown in FIG. 1, or can be of another suitablearrangement. The disclosed embodiments allow for coupling of the twostrap portions without the use of a buckle or other additionalcomponent. Preferably, one of the two strap portions includes anaperture and the other strap portion includes one or more notches thatare configured to engage the aperture as the strap portions are securelycoupled together. In some embodiments, the ends of the strap portionseach have a fastener, such as a hook and loop fastener, which areconfigured to fasten or couple the end to a surface of the other strapportion.

As illustrated in FIGS. 27-34, the headgear strap 2120 comprises afemale strap portion 2122 and a male strap portion 2124. The femalestrap portion 2122 includes a free end 2126 and an attached end 2141.The male strap portion has a free end 2128 and an attached end 2140.Preferably, the attached ends 2140 and 2141 are configured to bepermanently attached or integrally formed with other portions of theheadgear. In other embodiments, the attached ends 2140 and 2141 can beremovably attached or secured. The strap portions 2122 and 2124 can bemade of a flexible material and can be elastic or inelastic. In someembodiments the material of the strap portions 2122 and 2124 compriseslaminated layers of one or more polymers, foams or fabrics, such asBreath-o-prene. In some embodiments, the strap portions 2122 and 2124can have inner and outer fabric layers and a central foam or polymerlayer. Other flexible and durable materials may be suitable for thefemale and male straps 2122 and 2124. In other embodiments, the strapportions 2122 and 2124 can be formed from a central foam layer withnon-stretch or low-stretch inner and outer fabric layers.

Each of the free ends 2126 and 2128 of the female and male strapportions 2122 and 2124 preferably defines a grip member or tab that isconfigured to be grasped by a user during connection and adjustment ofthe headgear. The free ends 2126 and 2128 can be sized and shaped to beengaged and pulled on by the fingers of a user to move the strapportions 2122 and 2124 relative to one another. The grip members or tabsdefined by the free ends 2126 and 2128 can also be configured to be thinand substantially flat so that they lay flat against the opposite strapportion when the strap portions 2122 and 2124 are coupled.

Female strap portion 2122 has an inner surface 2136 and an outer surface2152. Male strap portion 2124 has an inner surface 2134 and an outersurface 2150. The inner surface 2136 of the female strap portion 2122supports a fastener 2142 and the inner surface 2134 of the male strapportion 2124 supports a fastener 2144. Preferably, fasteners 2142 and2144 are configured to couple or hold the free ends 2126 and 2128 of thefemale and male strap portions 2122 and 2124 to the outer surface of theopposite strap portion. In some embodiments, fasteners 2142 and 2144comprise hook and loop fastening systems (such as VELCRO®). Preferably,the outer surfaces 2150 and 2152 comprise a soft and/or textured fabricmaterial that forms the loop component of the hook and loop fastener.Fasteners 2142 and 2144 can include a plastic hook component that ispreferably fixed or permanently attached to the inner surface 2134, 2136of the female and male straps 2122 and 2124 at or adjacent the free ends2126 and 2128. The free ends 2126 and 2128 can be repeatedly coupled anddecoupled from the outer surfaces 2150 and 2152 of the strap portions.

Fasteners 2142 and 2144 are preferably located entirely within the outerperimeter of free ends 2126 and 2128 of the female and male strapportions 2122 and 2124, such that there are no sharp edges exposedbeyond the strap material. In the illustrated embodiment, the fastener2142 comprises a hook component having a width A of betweenapproximately 6 and 18 millimeters. In other embodiments, the width A isbetween approximately 10 and 14 millimeters. In another preferredembodiment, the width A is approximately 12 millimeters. The width B ofthe female and/or male strap portions 2122 and 2124 is preferablybetween approximately 10 and 24 millimeters and in some embodiments isbetween 16 and 20 millimeters. In another preferred embodiment, thewidth B is approximately 18 millimeters. Preferably, the difference inwidths A and B, in combination with the hook component being slightlyoffset from the tip of each free end 2126 and 2128, provides that theedges of the free ends 2126 and 2128 are not coupled or attached to theopposing strap portion. This allows the patient/user to be able to liftthe edges of the free ends 2126 and 2128 more easily for adjustment ofthe straps. The hook component can be the same for both the male andfemale strap portions.

Fasteners 2142 and 2144 can be secured in place on the straps by awelding process (ultrasonic or RF), adhesives, or any other form ofattachment. The straps can also include 3D features at or adjacent tothe free ends 2126 and 2128 of the strap portions 2122 and 2124. In someembodiments, by only welding the fasteners 2142 and 2144 and their hookcomponent portions in certain areas, protruding or dimpled surfaces 2148and 2149 can be formed in both the fasteners 2142 and 2144 and on theouter surfaces 2150 and 2152 of the strap portions. The dimpled surfaces2148 and 2149 are formed where the fastener's hook component and thestrap material have not been compressed by the welding process. Theregions of the fasteners 2142 and 2144 that are compressed during thewelding process may have the hooks crushed or deformed such that theycannot grip onto the loop component on the strap surfaces.

Fasteners 2142 and 2144 and their hook component portions are preferablythe same size and shape for both the female and male strap portions 2122and 2124, and they can be attached to the straps in the same manner Thisis advantageous because the two strap portions 2122 and 2124 can bemanufactured using a single process and tool. This minimizesmanufacturing times and costs. Also, the 3D features forming dimpledsurfaces 2148 and 2149 can provide improved tactile performance andusability of the free ends 2126 and 2128 of the female and male strapportions 2122 and 2124, such that it is easier to grip andcouple/decouple the free ends 2126 and 2128.

Male strap portion 2124 preferably comprises a plurality of notches 2132cut into one or more edges of the strap. In some embodiments, thenotches 2132 are arranged in pairs, such that a notch 2132 on one edgeof the strap portion 2124 is aligned with a corresponding notch 2132 onthe opposite edge of the strap portion 2124. Preferably, a plurality ofnotch pairs 2132 are spaced evenly along part of the length of the malestrap portion 2124, starting adjacent the free end 2128 and extendingtoward the attached end 2140. The notches 2132 are configured to provideincremental length adjustment of the headgear strap 2120. In theillustrated embodiment, there are two pairs of notches 2132 and eachnotch has a triangular or angled shape. The first pair of notches 2132is offset or distanced from the tip of the free end 2128 so that thefree end 2128 can define a tab or grasping portion between the notches2132 and the tip of the free end 2128. In other embodiments there may asfew as one pair of notches, and in others there can be three or morenotch pairs 2132 that provide more adjustment options for the strapconnection. Some embodiments can also have notches with different sizesand shapes. For example, some notches could be rectangular or circularin shape and could extend more or less into the edge of the strap. Inother embodiments, the strap 2124 can have a plurality of individualnotches along one edge of the strap 2124 without any notches along theopposite edge of the strap 2124. In such embodiments, the notch depthcan allow the strap portion 2124 to fit flat within the aperture 2130.Only a single notch would be engaged with the aperture 2130 at each sizesetting. In yet other embodiments, the strap 2124 can include aplurality of notches that alternate between sides along the length ofthe male strap portion 2124. In such embodiments, the notch depth canallow the strap 2124 to fit flat within the aperture 2130 and a singlenotch would be engaged with the aperture at each size setting.

The incremental adjustment provided by the notches 2132 allows forcontrolled adjustment of the headgear size, in comparison to thecontinuous adjustment provided by prior art systems. Controlledincremental adjustment can be beneficial as it provides precise sizingsettings that can be repeatedly selected. If the headgear is removedfrom the mask for cleaning, the female and male strap portions 2122 and2124 can be disconnected without the worry and inconvenience of losingthe sizing of the headgear and having to refit it to the specificpatient.

Female strap portion 2122 comprises an aperture 2130 that extendsthrough a portion or length of the female strap portion 2122.Preferably, aperture 2130 extends through the free end 2126 and extendsthrough the thickness of the strap portion 2122. The aperture 2130 canbe a cut-out or hole that extends through both the inner surface 2136and the outer surface 2152 of female strap portion 2122. Preferably, theaperture is offset or distanced from the tip of the free end 2126 suchthat the free end 2126 can be gripped between the aperture 2130 and thetip. The aperture 2130 is configured to receive the free end 2128 of themale strap portion 2124, thus linking the strap portions together. Thenotches 2132 of the male strap portion 2124 are configured to engage theaperture 2130 when the male strap portion 2124 passes through theaperture 2130. This arrangement of extending the male strap member 2124through the aperture 2130 of the female strap portion 2122 with portionsof the male strap member 2124 engaging the aperture 2130 can help tomaintain the female and male strap portions 2122 and 2124 linearlyaligned with each other, which provides consistent force vectors tosupport the mask on the patient's face. This arrangement can also helpmaintain a connection between the strap portions 2122 and 2124 duringadjustment. This makes adjustment easier as the user does not have tohold the headgear in place on his head while adjusting the length.

Preferably, the aperture 2130 is located within the perimeter of, andextends through a portion of the fastener 2142 on the female strapportion 2122, as shown in FIG. 27. The aperture 2130 can be punched outof the female strap portion 2122 as a secondary manufacturing step,after the fastener 2142 has been coupled to the strap portion 2122.Preferably, the aperture 2130 is positioned within a region of thefastener 2142 that is affixed or fused (by the welding process oradhesive) to the inner surface 2136, such that the hook component of thefastener 2142 is permanently joined around the entire perimeter of theaperture 2130. This reinforces the perimeter of the aperture 2130. Insome embodiments, the hooks of the hook component of the fastener 2142are crushed or deformed around the perimeter of the aperture 2130. Thereinforced perimeter provides structure to the aperture 2130 thatprevents it from deforming substantially as a result of forces appliedto it by the male strap portion 2124 being drawn through the aperture2130. This also makes it easier to draw the male strap portion 2124smoothly through the aperture 2130. The reinforced perimeter also helpsto engage the notches 2132 of the male strap portion 2124 duringadjustment of the headgear size. It also provides a tactile responseduring adjustment so that the user can feel when each pair of notches2132 is engaged and the size of the headgear has been adjusted by anincrement. Having the hooks of the hook component of the fastener 2142crushed or deformed adjacent to the perimeter of the aperture 2130 alsominimizes the chances of the male strap portion 2124 catching on thehooks during coupling and assembly. This may also improve the ease withwhich the male strap portion 2124 can be drawn through the aperture2130.

Preferably, aperture 2130 is sized and shaped so that the male strapportion 2124 is folded, bent or curved about its longitudinal axis inorder to pass through the aperture 2130. Preferably, the male strapportion 2124 is configured to lay flat within the aperture 2130 when itis arranged in a position in which notches 2132 are engaging theaperture 2130. In some embodiments, the width D of the male strapportion 2124 and its free end 2128 is greater than the width C or heightH of the aperture 2130. As illustrated, the aperture 2130 can beconfigured to have a straight side on its perimeter and also a curvedportion along the perimeter. The straight side extends perpendicular tothe longitudinal axis of the female strap portion 2122 and the curvedportion can be a semi-circular arc. In other preferred embodiments, theaperture can have a different shape such as triangular or square-shaped,wherein the height and width dimensions of the aperture allow the malestrap portion 2124 to pass through in a folded or bent position.Preferably, the width D of the male strap portion 2124 is betweenapproximately 10 and 24 millimeters and the width C of the aperture 2130is between approximately 5 and 14 millimeters. In other preferredembodiments, the width D is between approximately 16 and 20 millimetersand the width C is between approximately 8 and 10 millimeters. In onepreferred embodiment the width D is approximately 18 millimeters and thewidth C is approximately 9 millimeters. Is some preferred embodiments,the width D is approximately 1.5-2.5 times greater than the width C, andin one preferred embodiment the width D is approximately 2 times greaterthan the width C. Preferably, height H of aperture 2130 is less thanwidth C and is equal to or less than half the maximum width D of themale strap portion 2124.

The width J of male strap portion 2124 between notches 2132 isapproximately the same as width C of aperture 2130. This allows the malestrap portion 2124 to extend in a flat manner within aperture 2130 whenthe notches 2132 are aligned with and engaging the aperture 2130. Inother preferred embodiments, width J is less than width C. The curvedportion of aperture 2130 has a perimeter or arc measurement P thatdefines the distance or length along the perimeter of the aperture 2130,excluding the straight side of aperture 2130. The measurement P isapproximately the same as width D of the male strap portion 2124. Inother preferred embodiments, measurement P is slightly less than width Dand in other embodiments measurement P is greater than width D.Preferably, width B of female strap portion 2122 is approximately thesame as measurement P and width D. The female and male strap portions2122 and 2124 can have the same maximum widths B and D such that whenthe strap portions 2122 and 2124 are coupled, their edges do notprotrude or extend beyond one another, which provides a smooth andconsistent edge (as can be seen in FIG. 33). In one preferredembodiment, measurement P is approximately 18 millimeters.

By matching the perimeter measurement P of the aperture 2130 to themaximum width D of the male strap portion 2124, the size of the aperture2130 can be minimized, while still allowing passage of the strap portion2124 through the aperture 2130. Minimizing the size of the aperture 2130helps to maintain the structural integrity of the female strap portion2122 and maintains a close-fitting coupling between the female and malestrap portions 2122 and 2124. A close fit between the strap portions2122 and 2124 prevents unintentional disconnection of the straps.Allowing the male strap portion 2124 to flatten out when a pair ofnotches 2132 is aligned with the aperture 2130 permits the straps 2122and 2124 to maintain a low profile when coupled, as shown in FIG. 32.The notches 2132 can also function as an end stop feature, wherein thewidth of the male strap portion 2124 outside of the notches 2132prevents it from unintentionally slipping through the aperture 2130.

As illustrated, aperture 2130 is sized and shaped to allow the free end2128 of the male strap portion 2124 to pass through it, as shown in FIG.29. Both strap portions 2122 and 2124 can have approximately equalmaximum widths B and D. In order for a consistent maximum width to bemaintained along the lengths of the strap portions 2122 and 2124, theaperture 2130 preferably has a narrower width C than the maximum widthsB and D of the strap portions 2122 and 2124. For the male strap portion2124 to fit through the narrower aperture 2130, the strap portion 2124is folded or bent such that its width is reduced to match or be smallerthan the width C of the aperture 2130. In bending or folding the malestrap portion 2124, its depth is increased so the aperture 2130preferably has corresponding depth or height H. The dimensions ofaperture 2130 can be selected to allow for the increased depth of thestrap portion 2124 to pass through. Preferably, the hook component ofthe hook and loop fastener 2144 limits the ability of the male strapportion 2124 to be folded or bent to fit through the aperture 2130. FIG.30 shows the male strap portion 2124 being folded or bent as it passesthrough the aperture 2130. The hook component of the fastener 2144buckles and bunches and can limit how narrow the strap portion 2124 canbe bent, which in turn restricts how narrow the aperture width C can be.

As illustrated in FIG. 31, in order to adjust the headgear assembly andcouple the strap portions 2122 and 2124, free end 2128 of male strapportion 2124 extends through aperture 2130 and notches 2132 engage theaperture 2130. In this position, the male strap portion 2124 can layflat against the straight side of the aperture 2130 and the two strapportions 2122 and 2124 can be pressed flat against one another, as shownin FIGS. 32-34. The notches 2132 engaging the aperture 2130 assists inmaintaining the position of the male strap portion 2124 relative to thefemale strap portion 2122. Fastener 2142 on the female strap portion2122 engages the outer surface 2150 of male strap portion 2124 andfastener 2144 engages the outer surface 2152 of female strap portion2122. The fasteners 2142 and 2144 can hold the free ends 2126 and 2128against straps portions 2122 and 2124. The coupled strap portions 2122and 2124 are securely coupled and can have a low profile. In thismanner, the size adjustment for a headgear strap is built into the strapportions 2122 and 2124. No secondary component, such as a buckle orclip, is required to couple the strap portions. The strap portions 2124and 2122 are connected directly to each other and are adjustablerelative to one another. The amount of overlap between the strapportions 2122 and 2124 can determine the adjusted size for the headgear.This arrangement is advantageous at least because it has a low profileand is less bulky than a buckle. The arrangement also improves comfortof the patient as only the straps 2122 and 2124 are contacting the userand there are no hard parts that would cause discomfort. There are alsofewer components and therefore less assembly is required, andmanufacturing costs are reduced. It is also beneficial because itrequires only a single adjustment to change size (a buckle configurationrequires that each of the strap portions has to be individuallyadjusted), which means quicker and easier fitting of a mask.

FIG. 35 illustrates an embodiment of a headgear adjustment andconnection system that includes a pair of straps that are configured tobe linked together such that their combined length is continuouslyadjustable. The headgear strap assembly 2220 comprises a female strapportion 2222 and a male strap portion 2224. The female strap portion2222 includes a free end 2226 and the male strap portion 2224 has a freeend 2228. Preferably, the other ends of the strap portions areconfigured to be permanently attached or removably attached with otherportions of the headgear. Similar to the embodiments described above,strap portions 2222 and 2224 can be made of a flexible material and canbe elastic or inelastic. In some embodiments the material of the strapportions 2222 and 2224 comprises laminated layers of one or morepolymers, foams or fabrics, such as Breath-o-prene. In some embodiments,the strap portions 2222 and 2224 can have inner and outer fabric layersand a central foam or polymer layer.

Each of the free ends 2226 and 2228 of the male and female strapportions 2222 and 2224 preferably defines a grip member or tab that isconfigured to be grasped by a user during connection and adjustment ofthe headgear. The grip members or tabs defined by the free ends 2226 and2228 can also be configured to be thin and substantially flat so thatthey lay flat against the opposite strap portion when the strap portions2222 and 2224 are coupled.

In the illustrated embodiment, the female strap portion 2222 comprisesan aperture 2230. Preferably, the aperture 2230 extends through aportion or length of the female strap portion 2222. Preferably, aperture2230 extends through the free end 2226 and extends through the thicknessof the strap portion 2222. The aperture 2230 can be a cut-out or holethat extends through both the inner surface and the outer surface offemale strap portion 2222. Preferably, the aperture 2230 is offset ordistanced from the tip of the free end 2226 such that the free end 2226can be gripped between the aperture 2230 and the tip. The aperture 2230is configured to receive the free end 2228 of the male strap portion2224, thus linking the strap portions together.

The male strap portion 2224 includes an adjustment portion 2232 that ispreferably narrower than the surrounding portions of the male strapportion 2224. The adjustment portion 2232 is configured to enter and/orengage the aperture 2230 when the male strap portion 2224 passes throughthe aperture 2230. The adjustment portion 2232 has a length L and themale strap portion 2224 can be adjusted relative to the female strapportion 2222 at any position at which any portion of the adjustmentportion 2232 along its length L is aligned with the aperture 2230.Preferably, the free end 2226 includes a fastener 2242 and the free end2228 includes a fastener 2244. Each of the fasteners 2242 and 2244 isconfigured to engage and fasten to the outer surface of the oppositestrap portion, as described in the previous embodiments. Thisarrangement of extending the male strap member 2224 through the aperture2230 of the female strap portion 2222 with the adjustment portion 2232within the aperture 2230 can help to maintain the male and female strapportions 2222 and 2224 linearly aligned with each other, which providesconsistent force vectors to support the mask on the patient's face. Thisarrangement can also help maintain a connection between the strapportions 2222 and 2224 during adjustment. This arrangement furtherallows for continuous adjustment of the strap portions relative to oneanother throughout the length L so that the strap portions can beadjusted in very small increments to provide countless size options.This also makes adjustment easier as the user does not have to hold theheadgear in place on his head while adjusting the length.

Preferably, the male strap portion 2224 includes a transition 2266 atthe end of the adjustment portion 2232 that is configured to provide astop or engagement surface that deters decoupling of the strap portions2222 and 2224. The male strap portion 2224 can also include a transition2267 at the opposite end of the adjustment portion 2232 that isconfigured to provide an engagement surface or stop that limits movementof the aperture 2230 past that point and deters overtightening of thestrap portions.

As illustrated, the male strap portion 2224 has a width R and theadjustment portion 2232 has a width Q. The female strap portion 2222 hasa width T and the aperture has a width S. Preferably, the widths T and Rof the strap portions 2222 and 2224 are substantially the same. In onepreferred embodiment, the width Q of the adjustment portion 2232 isapproximately the same as the width S of the aperture 2230. In such anarrangement, there is little or no friction or engagement between theadjustment portion 2232 and the aperture 2230 as the adjustment portion2232 passes through the aperture 2230. However, the fasteners 2242 and2244 engage the surface of the opposite strap portion and retain thecoupling of the strap portions.

In another preferred embodiment, the widths R and T of the strapportions 2222 and 2224 are greater than the width Q of the adjustmentportion 2232. The width Q of the adjustment portion 2232 can also begreater than the width S of the aperture 2230. In such an embodiment,there is friction or engagement between the adjustment portion 2232 andthe aperture 2230 as the adjustment portion 2232 passes through theaperture 2230 which assists in the retention of the coupling of thestrap portions 2222 and 2224. The greater the width Q relative to thewidth S, the more friction there is and more force is required todecouple the strap portions 2222 and 2224 or adjust them relative to oneanother. In another embodiment, the width Q is substantially the same asthe width R of the strap portion 2224. In such an embodiment there arelittle or no transitions at the end of the adjustment portion 2230 tolimit overtightening or deter uncoupling of the strap portions 2222 and2224.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise”, “comprising”, and thelike, are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense, that is to say, in the sense of“including, but not limited to.”

Where, in the foregoing description reference has been made to integersor components having known equivalents thereof, those integers orcomponents are herein incorporated as if individually set forth.

The disclosed methods, apparatus and systems may also be said broadly tocomprise the parts, elements and features referred to or indicated inthe disclosure, individually or collectively, in any or all combinationsof two or more of said parts, elements or features.

Reference to any prior art in this specification is not, and should notbe taken as, an acknowledgement or any form of suggestion that thatprior art forms part of the common general knowledge in the field ofendeavour in any country in the world.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially,” as used herein represent avalue, amount or characteristic close to the stated value, amount orcharacteristic that still performs a desired function or achieves adesired result. The deviation from the stated value, amount orcharacteristic could, for example, reflect acceptable tolerances,conversion factors, rounding off, measurement error, or other factorsknown to those of skill in the art. For example, the terms “generallyparallel” and “substantially parallel” refer to a value, amount orcharacteristic that can depart from exactly parallel by less than orequal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1degree, or otherwise.

Although the present disclosure has been described in terms of certainembodiments, other embodiments apparent to those of ordinary skill inthe art also are within the scope of this disclosure. Thus, variouschanges and modifications may be made without departing from the spiritand scope of the disclosure. For instance, various components may berepositioned as desired. Moreover, not all of the features, aspects andadvantages are necessarily required to practice the present disclosure.Accordingly, the scope of the present disclosure is intended to bedefined only by the claims that follow.

1.-40. (canceled)
 41. A forehead coupler configured to connect first andsecond forehead straps of a headgear together in a closed loop andconnect the headgear to a frame comprising: a pair of lateral strapconnectors; and a frame connector configured to link the strapconnectors together; wherein the frame connector comprises a crossbarand a rib slot, the rib slot is formed within a thin flange that extendsupwardly from the crossbar and extends between the two strap connectors,the thin flange creating a recess on a front side of the frameconnector.
 42. The forehead coupler of claim 41, wherein the strapconnectors each comprise a strap aperture and a strap guide.
 43. Theforehead coupler of claim 41, wherein the crossbar has a cross-sectionalprofile comprising a first end and a second end connected by two flatsides.
 44. The forehead coupler of claim 43, wherein the first andsecond ends have semicircular profiles, wherein a diameter of the firstend is smaller than a diameter of the second end, wherein a length ofthe flat sides is greater than the diameter of the second end.
 45. Theforehead coupler of claim 43, wherein an acute angle is formed betweenthe flat sides.
 46. The forehead coupler of claim 41, wherein the frameconnector is offset from the strap connectors.
 47. The forehead couplerof claim 41, wherein the thin flange extends tangentially from a backside of the crossbar, thereby creating the recess on the front side ofthe frame connector.
 48. The forehead coupler of claim 41, wherein therib slot comprises two substantially vertical long edges separated by ahorizontal short edge parallel with the crossbar.
 49. The foreheadcoupler of claim 48, wherein the two long edges extend perpendicularlyfrom ends of the short edge and curve outwardly in an upwards direction.50. A connector system for connecting a headgear to a respiratory mask,the connector system comprising: a frame connected to the respiratorymask; and first and second forehead straps attached to the headgear,wherein the first and second forehead straps are attached to the framewith a forehead coupler to connect the headgear to the respiratory mask,the forehead coupler comprising: a pair of lateral strap connectors; anda frame connector configured to link the strap connectors together;wherein the frame connector comprises a crossbar and a rib slot, the ribslot is formed within a thin flange that extends upwardly from thecrossbar and extends between the two strap connectors, the thin flangecreating a recess on a front side of the frame connector.
 51. Theconnector system of claim 50, further comprising: a hook connectorportion disposed on the frame, the hook connector portion furthercomprising: a shank connected to the frame, a bend connected to theshank, a return arm connected to the bend, and a throat portionpositioned between the shank and the return arm, wherein the frameconnector of the forehead coupler is sandwiched between the shank andthe return arm such that the forehead coupler is removably attached tothe hook connector portion and the first and second forehead straps areremovably attached to the frame, the hook connector portion furthercomprising: a rib extending into the throat portion from the shanktoward the return arm, wherein the rib is positioned within the rib slotof the forehead coupler when the forehead coupler is attached to thehook connector portion and contact between the rib and the rib slotobstructs rotation of the forehead coupler relative to the frame. 52.The connector system of claim 51, wherein the rib is separated from thebend and the return arm.
 53. The connector system of claim 51, whereinthe frame connector of the forehead coupler includes a recess positionedon one side of the frame connector, wherein the recess contacts thereturn arm and obstructs the forehead coupler from being inserted intothe throat portion when the recess faces the return arm.
 54. Theconnector system of claim 51, wherein an end portion of the return armextends towards the shank to define a throat opening between the returnarm and the shank, wherein a width of the throat opening between thereturn arm and the shank is narrower than a width of the throat betweenthe return arm and the shank, wherein the width of the throat openingbetween the return arm and the shank is narrower than a thickness of theforehead straps, wherein a thickness of an end of the frame connector ofthe forehead coupler is greater than double the width of the throatopening.
 55. The connector system of claim 51, wherein the frame is auniversal frame configured to fit a plurality of respiratory mask sizes,wherein a position of the frame connector of the forehead coupler withrespect to the strap connectors varies between a smaller-sizedrespiratory mask and a larger-sized respiratory mask, wherein,comparatively, the position of the frame connector of the foreheadcoupler with respect to the strap connectors for the smaller-sizedrespiratory mask is positioned vertically higher than the frameconnector of the forehead coupler with respect to the strap connectorsfor the larger sized respiratory mask such that the strap connectors forthe smaller-sized respiratory mask are positioned lower with respect tothe universal frame than the strap connectors for the larger sizedrespiratory mask.